Clinical Development of MR Spectroscopy and Imaging in Brain Cancers
NCT ID: NCT02731521
Last Updated: 2022-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
112 participants
OBSERVATIONAL
2014-01-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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
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
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
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Cancer Prevention Research Institute of Texas
OTHER
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Principal Investigators
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Changho Choi, PhD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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STU 122013-077
Identifier Type: -
Identifier Source: org_study_id
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