Malignant GliomasNCT02731521
Clinical Development of MR Spectroscopy and Imaging in Brain Cancers
An observational study of Malignant Gliomas and Astrocytomas, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Gliomas, Astrocytomas, Oligodendrogliomas
- What is being tested?
- 3 Tesla Scanning and 7 Tesla Scanning
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Glioma patients recruited from UTSW neurosurgery and neuro-oncology clinics.
Who may be able to join
- (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)
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- 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
Who cannot join
- Under age 18
- Cardiac pacemaker
- Intracranial clips, metal implants, or external clips within 50 cm from the head
- Metal in eye
- Pregnancy
- Claustrophobia
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malignant Gliomas, Astrocytomas, Oligodendrogliomas
- Being tested
- 3 Tesla Scanning, 7 Tesla Scanning
- Keywords
- MRS Biomarkers
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Tesla ScanningDevice
Also called 3T MRI/MRS
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 ScanningDevice
Also called 7T MRI/MRS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 3 Tesla Scanning; Device: 7 Tesla Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measuring amount of 2-hydroxygluterate (2HG) biomarker with MRS.
Measured: 1-4 scans, average over 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomasStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Changho Choi, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731521
- Sponsor's protocol ID
- STU 122013-077
- Status last verified
- Jan 2022
- First submitted
- 2 Mar 2016
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Development of MR Spectroscopy and Imaging in Brain Cancers
- ClinicalTrials.gov ID
- NCT02731521
- Acronym / sponsor ID
- STU 122013-077
- Conditions
- Malignant Gliomas, Astrocytomas, Oligodendrogliomas
- Keywords
- MRS Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 Tesla Scanning and 7 Tesla Scanning | – | Device: 3 Tesla Scanning, Device: 7 Tesla ScanningScanning at 3 Tesla and 7 Tesla: Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS) of glioma and non-glioma patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Glioma patients recruited from UTSW neurosurgery and neuro-oncology clinics.
Key inclusion criteria (17 listed)
- (120 Brain Tumor Patients)
- All races and ethnicities
- Must meet at least one of the 3 following criteria regarding diagnosis:
- 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.
Key exclusion criteria (13 listed)
- Under age 18
- Cardiac pacemaker
- Intracranial clips, metal implants, or external clips within 50 cm from the head
- Metal in eye
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 Tesla ScanningAlso: 3T MRI/MRSApproximately 120 brain tumor patients 50 patients with non-glioma disease, and 5 healthy volunteers will be scanned at either 3 Tesla or 7 Tesla. | Device | 3 Tesla Scanning and 7 Tesla Scanning |
| 7 Tesla ScanningAlso: 7T MRI/MRSApproximately 120 brain tumor patients 50 patients with non-glioma disease, and 5 healthy volunteers will be scanned at either 3 Tesla or 7 Tesla. | Device | 3 Tesla Scanning and 7 Tesla Scanning |
Primary outcome
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).
Time frame: 1-4 scans, average over 36 months
Measuring amount of 2-hydroxygluterate (2HG) biomarker with MRS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changho Choi, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Gliomas and Astrocytomas, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 1-4 scans, average over 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.