Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02731521
• Collaborator: Cancer Prevention Research Institute of Texas (Other)
• Enrollment: 112
• Location: 1
• Duration (Months): 96
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in isocitrate dehydrogenase (IDH) mutated gliomas and IDH wild type gliomas.

Condition or Disease	Intervention/Treatment	Phase
Malignant Gliomas; Astrocytomas; Oligodendrogliomas	Device: 3 Tesla Scanning; Device: 7 Tesla Scanning

Detailed Description

2-hydroxyglutarate (2HG) imaging will identify glioma, tumor progression and response to therapy noninvasively at an earlier time point than currently detectable with standard MR imaging. This utility of 2HG can be used for improving the patient care in a more effective manner when the 2HG imaging is incorporated in regular clinical MR scans in brain tumor patients. We aim to translate the 2HG MRS protocol into two clinical MR centers at UTSouthwestern Medical Center: The Mary Nell and Ralph B. Rogers Magnetic Resonance Center with Philips 1.5Tesla and 3Tesla scanners and The Algur H. Meadows Diagnostic Imaging Center with a GE 3Tesla scanner. In addition, we will perform Magnetic Resonance (MR) scans in patients with neurological diseases that can mimic gliomas, including stroke, epilepsy, encephalitis, and brain metastases in order to establish the specificity of 2HG to malignant gliomas.

Study Design

• Study Type: Observational
• Actual Enrollment: 112 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Clinical Development of MR Spectroscopy and Imaging in Brain Cancers
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
3 Tesla Scanning and 7 Tesla Scanning Scanning at 3 Tesla and 7 Tesla: Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS) of glioma and non-glioma patients.	Device: 3 Tesla Scanning; Approximately 120 brain tumor patients 50 patients with non-glioma disease, and 5 healthy volunteers will be scanned at either 3 Tesla or 7 Tesla.; Other Names: 3T MRI/MRS ; Device: 7 Tesla Scanning; Approximately 120 brain tumor patients 50 patients with non-glioma disease, and 5 healthy volunteers will be scanned at either 3 Tesla or 7 Tesla.; Other Names: 7T MRI/MRS

Outcome Measures

Primary Outcome Measures

1. Amount of 2-hydroxyglutarate (2HG) bio-marker in 170 patients with clinically-proven brain metastasis, multiple sclerosis, epilepsy, stroke, or encephalitis using magnetic resonance spectroscopy (MRS). [1-4 scans, average over 36 months]

   Measuring amount of 2-hydroxygluterate (2HG) biomarker with MRS.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

(120 Brain Tumor Patients)

• All races and ethnicities

• Must meet at least one of the 3 following criteria regarding diagnosis:

• Histological diagnosis of a brain tumor

• Pre-operative MR imaging suggestive of a brain tumor

• Radiographic diagnosis of brain tumor in an inoperable location (e.g. brainstem)

• Pretreatment evaluations required for eligibility include a medical history, physical examination, and neurological exam within 30 days prior to study entry.

• Patient must be able to provide study-specific consent prior to study entry and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.

• Karnofsky performance status >70%

• Life expectancy greater than 3 months.

(50 Non-Tumor Neurological Disorders)

• All races and ethnicities

• Patients with clinically-proven multiple sclerosis, temporal lobe epilepsy, stroke, or encephalitis.

(5 Health Volunteers)

• 18-40 years of age

• All races and ethnicities

• Excellent general health

Exclusion Criteria:

• Under age 18

• Cardiac pacemaker

• Intracranial clips, metal implants, or external clips within 50 cm from the head

• Metal in eye

• Pregnancy

• Claustrophobia

• Obesity or any other factors that provide difficulty with supine pose in the magnet

• Patients who are unable to provide informed consent

• Patients who are pregnant or nursing

• Patients with severe kidney dysfunction or uncontrolled cardiac dysfunction

• Patients who are claustrophobic or have other contraindication to MRI, such as implanted pacemaker device, vascular clips, surgical clips, prosthetic valves, pace¬makers, otologic implants

• Patients with uncontrolled psychiatric manifestations of their brain tumor

• Patients for 7 Tesla scans can have no metal in the body

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center
• Cancer Prevention Research Institute of Texas

Investigators

• Principal Investigator: Changho Choi, PhD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02731521
• Other Study ID Numbers: STU 122013-077
• First Posted: Apr 7, 2016
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by University of Texas Southwestern Medical Center: MRS Biomarkers
• Additional relevant MeSH terms: Astrocytoma; Glioma; Oligodendroglioma; Brain Neoplasms

Study Results

No Results Posted as of Feb 3, 2022