Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02387840
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 6
• Duration (Months): 53
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors. This study will also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that affects the growth of nervous system cells. Further, it will explore potential ways of using of MRF signal measurements in children, adolescents, and young adults with brain tumors, including tissue characterization, looking at whether the treatment was effective, and finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and potential applications of MRF, this study will recruit up to 80 subjects but will stop once 10 subjects have usable data in each of six groups.

Condition or Disease	Intervention/Treatment	Phase
Neurofibromatosis Type 1; Brain Tumor; Glioma	Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting	N/A

Detailed Description

Specific Aim 1: Demonstrate the feasibility of magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors.

Specific Aim 2: Characterize the MRF signature of low-grade gliomas

Specific Aim 3: Determine whether MRF can identify occult tumor in subjects with low-grade glioma.

Specific Aim 4: Determine whether MRF can identify treatment effects in low-grade gliomas.

Specific Aim 5: Explore whether common brain tumors can be differentiated by comparing pre-operative MRF signature with pathologic diagnosis.

Outline: This study will examine the feasibility of MRF in children and AYA and determine whether quantitative measures of T1 and T2 relaxation times can be derived in subjects <35 years of age. Approximately 80 subjects will be evaluated and include subgroups where MRF may be of particular utility, including children and AYA subjects with brain tumors and subjects with neurofibromatosis type 1 (NF1). Additional aims will investigate the utility of MRF in these groups.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Feasibility and Clinically Application of Magnetic Resonance Fingerprinting
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NF1-associated Optic Pathway Glioma (OPG) Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting	Device: Magnetic Resonance Imaging; Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.; Other Names: MRI ; Device: Magnetic Resonance Fingerprinting; Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).; Other Names: MRF
Experimental: NF1 without brain tumor Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting	Device: Magnetic Resonance Imaging; Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.; Other Names: MRI ; Device: Magnetic Resonance Fingerprinting; Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).; Other Names: MRF
Experimental: Without NF1 and with brain tumor exposed to therapy Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting	Device: Magnetic Resonance Imaging; Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.; Other Names: MRI ; Device: Magnetic Resonance Fingerprinting; Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).; Other Names: MRF
Experimental: Without NF1 and with untreated low grade brain tumors Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting	Device: Magnetic Resonance Imaging; Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.; Other Names: MRI ; Device: Magnetic Resonance Fingerprinting; Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).; Other Names: MRF
Experimental: Without NF1 and without brain tumors Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting	Device: Magnetic Resonance Imaging; Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.; Other Names: MRI ; Device: Magnetic Resonance Fingerprinting; Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).; Other Names: MRF
Experimental: Brain tumors of assorted pathology Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting	Device: Magnetic Resonance Imaging; Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.; Other Names: MRI ; Device: Magnetic Resonance Fingerprinting; Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).; Other Names: MRF

Outcome Measures

Primary Outcome Measures

1. Average Duration of MRF Sequence - Feasibility [Up to 1 year]

   The duration of MRF sequence in minutes will be recorded as a measure of feasibility

Secondary Outcome Measures

1. Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans [Up to 1 year]

   Number of patients which have evaluable scans at both T1 and T2

2. Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue [Up to 1 year]

   Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between low-grade (composite of arms 1,3,4) and versus healthy brain tissue.

3. Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue [Up to 1 year]

   Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between high-grade (arm 6) and versus healthy brain tissue.

4. Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG) [Up to 1 year]

   Using paired t-tests or non-parametric Wilcoxon signed rank tests, researchers will identify scans with significant differences in scans of treated and untreated tumors

Other Outcome Measures

1. Comparison of Relaxometry Values Between Tumors of Varying Pathology [Up to 1 year]

   Descriptive statistics will be used to identify the T1 and T2 relaxation times for tumors of different types on pre-operative MRF scan

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects undergoing MRI evaluation of the brain

• NF1 status will be determined by clinical exam or genetic testing

• NF1-associated Optic Pathway Glioma (OPG) will be defined as radiographic evidence of glioma along the optic nerve, chiasm, tract or radiation in a child with NF1

• Untreated low grade gliomas will be imaging-defined gliomas that have not yet been exposed to radiation or systemic chemotherapy. Those exposed to therapy will have had radiation and/or systemic chemotherapy more than 1 month prior to scans

Exclusion Criteria:

• History of mental retardation unrelated to brain tumor

• Presence of a genetic disorder other than NF1 that effects cognition or is associated with MR imaging abnormalities (e.g. tuberous sclerosis)

• History of cerebrovascular accident (stroke)

• Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth

• Major psychiatric diagnosis prior to neuro-oncological diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Deborah R Gold, MD, Case Comprehensive Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 21, 2016
• Informed Consent Form - Oct 26, 2017

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02387840
• Other Study ID Numbers: CASE7314; NCI-2015-00301
• First Posted: Mar 13, 2015
• Last Update Posted: Jan 12, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Case Comprehensive Cancer Center: Brain; Cancer; Neurofibromatosis type 1; NF1; Magnetic resonance fingerprinting; MRF
• Additional relevant MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma

Study Results

Participant Flow

Pre-assignment Detail	Protocol enrollment was 35 but data are only available for 34 participants - Study team believes one participant's scan was never completed with MRF but because the study was terminated in 2018 with no further access to data this cannot be confirmed.

Arm/Group Title	NF1-associated Optic Pathway Glioma (OPG)	NF1 Without Brain Tumor	Without NF1 and With Brain Tumor Exposed to Therapy	Without NF1 and With Untreated Low Grade Brain Tumors	Without NF1 and Without Brain Tumors	Brain Tumors of Assorted Pathology
Arm/Group Description	Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Period Title: Overall Study
STARTED	4	6	6	8	4	6
COMPLETED	4	6	6	8	4	5
NOT COMPLETED	0	0	0	0	0	1

Baseline Characteristics

Arm/Group Title	NF1-associated Optic Pathway Glioma (OPG)	NF1 Without Brain Tumor	Without NF1 and With Brain Tumor Exposed to Therapy	Without NF1 and With Untreated Low Grade Brain Tumors	Without NF1 and Without Brain Tumors	Brain Tumors of Assorted Pathology	Total
Arm/Group Description	Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Total of all reporting groups
Overall Participants	4	6	6	8	4	6	34
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	4.5	17.5	14	15	12.5	14	15
Sex: Female, Male (Count of Participants)
Female	2 50%	3 50%	4 66.7%	6 75%	3 75%	0 0%	18 52.9%
Male	2 50%	3 50%	2 33.3%	2 25%	1 25%	6 100%	16 47.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	4 100%	6 100%	6 100%	8 100%	4 100%	6 100%	34 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	4 100%	6 100%	6 100%	8 100%	4 100%	6 100%	34 100%
Region of Enrollment (participants) [Number]
United States	4 100%	6 100%	6 100%	8 100%	4 100%	6 100%	34 100%

Outcome Measures

1. Primary Outcome

Title	Average Duration of MRF Sequence - Feasibility
Description	The duration of MRF sequence in minutes will be recorded as a measure of feasibility
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Participants enrolled in study

Arm/Group Title	NF1-associated Optic Pathway Glioma (OPG)	NF1 Without Brain Tumor	Without NF1 and With Brain Tumor Exposed to Therapy	Without NF1 and With Untreated Low Grade Brain Tumors	Without NF1 and Without Brain Tumors	Brain Tumors of Assorted Pathology
Arm/Group Description	Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Measure Participants	4	6	6	8	4	6
Mean (Standard Deviation) [minutes]	11 (0)	11 (0)	11 (0)	11 (0)	11 (0)	11 (0)

2. Secondary Outcome

Title	Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans
Description	Number of patients which have evaluable scans at both T1 and T2
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Participants enrolled in study

Arm/Group Title	NF1-associated Optic Pathway Glioma (OPG)	NF1 Without Brain Tumor	Without NF1 and With Brain Tumor Exposed to Therapy	Without NF1 and With Untreated Low Grade Brain Tumors	Without NF1 and Without Brain Tumors	Brain Tumors of Assorted Pathology
Arm/Group Description	Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Measure Participants	4	6	6	8	4	6
Count of Participants [Participants]	4 100%	6 100%	6 100%	8 100%	4 100%	6 100%

3. Secondary Outcome

Title	Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue
Description	Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between low-grade (composite of arms 1,3,4) and versus healthy brain tissue.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Participants enrolled on arms 1,3 and 4. Combination of Arms 1, 3, and 4 for reporting was pre-specified in the study protocol. Each participant had a single tumor sample measured and a single normal-appearing white matter measured.

Arm/Group Title	Arms 1, 3, and 4 - Low Grade Gliomas	Arms 1, 3, and 4 - Normal Appearing White Matter
Arm/Group Description	Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 3: Without NF1 and with brain tumor exposed to therapy Arm 4: Without NF1 and with untreated low grade brain tumors	Arms 1, 3, and 4 - Normal appearing white matter
Measure Participants	18	18
T1	1355 (187)	916 (78)
T2	56 (19)	38 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NF1-associated Optic Pathway Glioma (OPG), NF1 Without Brain Tumor
	Comments	Comparison of T1 values
	Type of Statistical Test	Other
	Comments	This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NF1-associated Optic Pathway Glioma (OPG), NF1 Without Brain Tumor
	Comments	Comparison of T2 values
	Type of Statistical Test	Other
	Comments	This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue
Description	Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between high-grade (arm 6) and versus healthy brain tissue.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Participants in arm 6 had a measurable solid portion of HGG and were used for this analysis. Each participant had a single tumor sample measured and a single normal-appearing white matter measured.

Arm/Group Title	Arm 6 - High Grade Gliomas	Arm 6 - Normal Appearing White Matter
Arm/Group Description	Arm 6 - High Grade Gliomas	Arm 6 - Normal appearing white matter
Measure Participants	3	3
T1	1863 (70)	979 (156)
T2	91 (13)	45 (7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NF1-associated Optic Pathway Glioma (OPG), NF1 Without Brain Tumor
	Comments	Comparison of T1 values
	Type of Statistical Test	Other
	Comments	This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different
Statistical Test of Hypothesis	p-Value	0.081
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NF1-associated Optic Pathway Glioma (OPG), NF1 Without Brain Tumor
	Comments	Comparison of T2 values
	Type of Statistical Test	Other
	Comments	This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different
Statistical Test of Hypothesis	p-Value	0.081
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)
Description	Using paired t-tests or non-parametric Wilcoxon signed rank tests, researchers will identify scans with significant differences in scans of treated and untreated tumors
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Participants enrolled in study. Combination of Arms for reporting was pre-specified in the study protocol

Arm/Group Title	Arms 1 & 4 - Untreated LGG	Arms 1 & 3 - Treated LGGs
Arm/Group Description	Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 4: Without NF1 and with untreated low grade brain tumors The untreated LGG group consisted of Arm 4 and untreated participants from Arm 1.	Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 3: Without NF1 and with brain tumor exposed to therapy The Treated LGG group consisted of Arm 3 and treated patients from Arm 1
Measure Participants	9	7
T1	1410 (180)	1265 (181)
T2	57 (15)	47 (15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NF1-associated Optic Pathway Glioma (OPG), NF1 Without Brain Tumor
	Comments	Comparison of T1 values
	Type of Statistical Test	Other
	Comments	This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NF1-associated Optic Pathway Glioma (OPG), NF1 Without Brain Tumor
	Comments	Comparison of T2 values
	Type of Statistical Test	Other
	Comments	This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Other Pre-specified Outcome

Title	Comparison of Relaxometry Values Between Tumors of Varying Pathology
Description	Descriptive statistics will be used to identify the T1 and T2 relaxation times for tumors of different types on pre-operative MRF scan
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Up to 1 year
Arm/Group Title	NF1-associated Optic Pathway Glioma (OPG)		NF1 Without Brain Tumor		Without NF1 and With Brain Tumor Exposed to Therapy		Without NF1 and With Untreated Low Grade Brain Tumors		Without NF1 and Without Brain Tumors		Brain Tumors of Assorted Pathology
Arm/Group Description	Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).		Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).		Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).		Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).		Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).		Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
All Cause Mortality
	NF1-associated Optic Pathway Glioma (OPG)		NF1 Without Brain Tumor		Without NF1 and With Brain Tumor Exposed to Therapy		Without NF1 and With Untreated Low Grade Brain Tumors		Without NF1 and Without Brain Tumors		Brain Tumors of Assorted Pathology
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/6 (0%)		0/6 (0%)		1/8 (12.5%)		0/4 (0%)		1/6 (16.7%)
Serious Adverse Events
	NF1-associated Optic Pathway Glioma (OPG)		NF1 Without Brain Tumor		Without NF1 and With Brain Tumor Exposed to Therapy		Without NF1 and With Untreated Low Grade Brain Tumors		Without NF1 and Without Brain Tumors		Brain Tumors of Assorted Pathology
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/8 (0%)		0/4 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	NF1-associated Optic Pathway Glioma (OPG)		NF1 Without Brain Tumor		Without NF1 and With Brain Tumor Exposed to Therapy		Without NF1 and With Untreated Low Grade Brain Tumors		Without NF1 and Without Brain Tumors		Brain Tumors of Assorted Pathology
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/8 (0%)		0/4 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.