Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

NCT ID: NCT02731521

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Gliomas Astrocytomas Oligodendrogliomas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

3 Tesla Scanning

Intervention Type DEVICE

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.

7 Tesla Scanning

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

3T MRI/MRS 7T MRI/MRS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Changho Choi, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU 122013-077

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors
NCT06209567 ACTIVE_NOT_RECRUITING EARLY_PHASE1
Indocyanine Green for Central Nervous System Tumors
NCT02710240 COMPLETED PHASE1/PHASE2