Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence

Sponsor

Nicole Baca (Other)

Overall Status

Recruiting

CT.gov ID

NCT04763109

Collaborator

(none)

Enrollment

Location

Arm

33.8

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single arm pilot trial of a novel whole-body Magnetic Resonance Imaging paired with artificial intelligence intervention, to evaluate feasibility defined as scan-rescan reliability, and to estimate the positive predictive value of changes in Magnetic Resonance Imaging scans from baseline to 12-month visit using an Artificial Intelligence algorithm, among 15 pediatric patients with neurofibromatosis type 1 at Cedars-Sinai Medical Center.

Condition or Disease	Intervention/Treatment	Phase
Neurofibromatosis Type 1	Other: Whole-body Magnetic Resonance Imaging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence

Actual Study Start Date :

Jul 8, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Whole-Body Magnetic Resonance Imaging	Other: Whole-body Magnetic Resonance Imaging Whole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months

Arm

Intervention/Treatment

Experimental: Whole-Body Magnetic Resonance Imaging

Other: Whole-body Magnetic Resonance Imaging

Whole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months

Outcome Measures

Primary Outcome Measures

For scan re-scan reliability, utilize T2 imaging to evaluate the agreement between the baseline scan and the 1 Month scan, which is performed within 4 weeks of the baseline scan. [From Baseline to within 4 weeks of baseline]
T2 is a type of high-resolution multiparametric tissue mapping that measures quantitative metrics of the physical properties of tissue and allows comparison in longitudinal follow-up

Secondary Outcome Measures

For change over time, the initial scan imaging using T1 and apparent diffusion coefficient (ACD) imaging, the baseline scan will be compared to the third scan, which is performed 12 months (+/- 3 months) after the baseline scan. [From Baseline to 12 months]
T1 and ACD is a type of high-resolution multiparametric tissue mapping that measures quantitative metrics of the physical properties of tissue and allows comparison in longitudinal follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Between the ages of 5 and <18 years at the start of study. If subject will turn 18 during the study, they will be allowed to enroll.
Clinically or molecularly confirmed diagnosis of NF-1. Subjects with mosaic/segmental NF-1 also qualify for the study.

Exclusion Criteria:

Requiring sedation for imaging.
Implants and/or Devices: Mechanical, magnetic or electrical activated implants; Ferromagnetic implants and foreign bodies
Claustrophobia, problems being in enclosed spaces, or inability to lie facing upwards.
Allergy to animal dander or animal-instigated asthma.