Scientists watch brain tumors transform using advanced imaging
NCT ID NCT03952598
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 11 times
Summary
This study tracks a substance called 2-HG in the brains of people with a type of brain cancer (glioma) that has specific gene changes. By using special MRI scans over time, researchers hope to learn how and when these tumors become more aggressive. About 42 adults will have regular scans and check-ups for life, but no new treatment is being tested.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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42 people
The number who actually took part.
- Started
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Oct 2019
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Participants must have histologically confirmed diffuse glioma with documented IDH1 or IDH2 mutation, confirmed by DNA sequencing the exception will be participants with brain lesions that are not safe for biopsy but clinically suspected to be diffuse glioma are allowed to enroll to the study to receive imaging study as part of the exploratory study * Participants must have measurable disease. * Age \>=18 years. Tumor biology of IDH-mutant gliomas are different in pediatric tumors. Therefore, children will be excluded from the study. * Karnofsky performance \>= 70%. * Participants must have documented normal kidney function as defined below: Creatinine within normal institutional limits OR Creatinine clearance \>60 mL/min/1.73 m2 for Participants with creatinine levels above institutional normal (Measured or calculated creatinine clearance -Participants must have adequate liver function as defined below: total bilirubin \<=2x ULN (ULN 1.3 mg/dl) except for participants with Gilbert Syndrome AST \< 3x ULN (ULN 34U/L) ALT \< 3x ULN (ULN 55U/L) -Ability of participants to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study, and that this is not a therapeutic clinical trial. EXCLUSION CRITERIA: * Participants who have contraindication to MRI examination, including, but not limited to, unable to receive gadolinium, medical instability, or any contraindication on MR Screening Form. Pregnant individuals are excluded because MRI contrast, planned to be used on this study, may be dangerous for the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to using of MRI contrast, breastfeeding should be discontinued for 72 hours following study imaging. * Participants weighing \> 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry * Poorly controlled hypertension, with blood pressure \>150/90 mmHg. * Congestive heart failure with New York Heart Association (NYHA) status \> 2. * A medical history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG. * Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma with an exacerbation within the past year.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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