Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma
United States12 participantsStarted 2023-04-11
Plain-language summary
This study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must have a life expectancy \> 8 weeks.
. Participants must have a Karnofsky performance status of \> 70.
. Participants must have adequate renal function (creatinine \< 1.5 mg/dL). This test must be performed within 60 days prior to the HP 13C Imaging scan.
. Participants must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the participant's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
. Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.
. Participants must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
Exclusion criteria
. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Participants must sign an authorization for the release of their protected health information.
. Participants may not be known to be HIV-positive. HIV testing is not required for study participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean signal to noise ratio of HP 13C-aKG
Timeframe: Day of imaging (1 day)
2
Mean signal to noise ratio of oncometabolite 2-hydroxyglutarate (2-HG)
Timeframe: Day of imaging (1 day)
3
Mean signal to noise ratio of of glutamate
Timeframe: Day of imaging (1 day)
4
Median signal to noise ratio of 2HG to aKG
Timeframe: Day of imaging (1 day)
5
Mean signal to noise ratio of 2HG to glutamate
Timeframe: Day of imaging (1 day)
6
Proportion of participants who reported treatment-emergent adverse events
Timeframe: Day of imaging (1 day)
7
Comparison of HP 13C 2HG/aKG ratio with surgical results (Cohort 2)
0. Participants must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years.
1. Participants must not be pregnant or breast-feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of childbearing potential.
Comparison of HP 13C 2HG/glutamate ratio with surgical results (Cohort 2)
Timeframe: Day of imaging (1 day)
9
Comparison of HP 13C glutamate/aKG ratio with surgical results (Cohort 2)