Clinical Development of Cancer-Specific MRS Biomarkers in Malignant Gliomas

NCT02388659 | Completed

• 2 other identifiers: STU022014-048R01CA184584
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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 IDH mutated gliomas and IDH wild type gliomas.

Conditions

Malignant Gliomas; Oligodendrogliomas; Astrocytomas

Keywords

MRS Biomarkers

Outcome Measures

Primary Outcomes (1)

• Identification of 2-hydroxygluterate (2HG) biomarker in 30 patients with clinically-proven brain metastasis, multiple sclerosis, epilepsy, stroke, or encephalitis using magnetic resonance spectroscopy (MRS).

  The investigators anticipate the study will provide significant value in many aspects of management of gliomas. 3D evaluation of the cancer biomarkers using MRSI will provide biological insights for making the diagnosis of gliomas, tracking of infiltrative cells during follow up, and determining response to treatment.

  8 scans, average 36 months

Study Arms (1)

Brain MRI/MRS Patients

3 Tesla Scanning: MRI/MRS of glioma and non-glioma patients.

Device: 3 Tesla scanning

Interventions

3 Tesla scanning DEVICE

Approximately 38 brain tumor patients with IDH mutated gliomas and 50 patients with non-glioma disease will be scanned.

Also known as: 3T MRI/MRS

Brain MRI/MRS Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age and over with brain tumors and patients 18 years of age and over with non-tumor neurological disorders.

You may qualify if:

• Patients with brain tumors (55 subjects):
• Age \> 18 years
• Males and females
• All races and ethnicity
• Patients must meet at least one of the 3 following criteria regarding brain tumor diagnosis:
• Histological diagnosis of a brain tumor
• Pre-operative brain MR imaging suggestive of a brain tumor
• Radiographic diagnosis of brain tumor in an inoperable location (e.g. brainstem)
• Pretreatment evaluation 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%
• Patients with non-tumor neurological disorders (50 subjects):
• Males and females
• All races and ethnicities
• Patients with clinically-proven encephalitis (infections, autoimmune and paraneoplastic), demyelinating lesions, vascular lesions (subacute arterial infarct, venous infarct, and vasculitis), hamartomatous lesions, and malformations of cortical development.

You may not qualify if:

• Age under 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 cips, surgical slips, prosthetic valves, pacemakers, otologic implants.
• Patients with uncontrolled psychiatric manifestations of their brain tumor.
• Children (age \< 18) are excluded from the study plan because the incidence of astrocytomas and glioblastoma in children is far less than in adults. Although children frequently develop brain tumors, the glial tumors are most often pilocytic astrocytomas. In addition, enrollment of adults will be beneficial for the MRS sequence validation tests in healthy subjects since adults can remain motionless during the MR scans compared to children, giving minimal motion artifacts om the MR data.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Glioma; Oligodendroglioma; Astrocytoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Changho Choi, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 17, 2015
• Study Start: February 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)