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Metabolic Imaging Agent
HP C13-aKG MRI for Brain Tumor
Phase < 1
Recruiting
Led By Susan Chang, MD
Research Sponsored by Robert Bok, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of imaging (1 day)
Awards & highlights
Study Summary
This trial looks at using a special kind of imaging to measure tumor burden in people with a type of brain tumor.
Who is the study for?
This trial is for adults over 18 with IDH mutant glioma brain tumors. They must have good kidney function, no severe medical illnesses, heart failure, recent heart attacks or unstable angina. Life expectancy should be more than 8 weeks and a performance status indicating they can carry out daily activities. Pregnant or breastfeeding women are excluded, as well as those with other cancers unless in remission for 3+ years.Check my eligibility
What is being tested?
The study tests a new imaging technique using Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP C13-aKG) alongside MRI to assess tumor burden in patients with specific brain tumors. It aims to improve how we visualize the size and location of these tumors.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from lying still during an MRI scan and reactions related to the HP C13-aKG agent such as mild allergic responses or temporary changes in sensation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of imaging (1 day)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of imaging (1 day)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of HP 13C 2HG/aKG ratio with surgical results (Cohort 2)
Comparison of HP 13C 2HG/glutamate ratio with surgical results (Cohort 2)
Comparison of HP 13C glutamate/aKG ratio with surgical results (Cohort 2)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)Experimental Treatment2 Interventions
Cohort 2 will be comprised 30 participants with recurrent IDH mutant glioma before receiving surgical resection. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan.
Group II: Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)Experimental Treatment2 Interventions
Cohort 1 will be comprised of 10 participants with Isocitrate dehydrogenase (IDH) mutant glioma who may or may not have received prior treatment for optimizing imaging protocol. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan.
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Who is running the clinical trial?
Robert Bok, MD, PhDLead Sponsor
1 Previous Clinical Trials
65 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,608 Total Patients Enrolled
Susan Chang, MDPrincipal InvestigatorUniversity of California, San Francisco
6 Previous Clinical Trials
246 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart failure.I do not have HIV.My glioma has recurred and has an IDH mutation, and I haven't had surgery yet.I am aware the study is open to all genders and minorities.I haven't had a heart attack or unstable chest pain in the last year.My glioma is IDH mutant, with or without prior treatment.I have been cancer-free for at least 3 years, if I had another type of cancer.My kidney function is good (creatinine < 1.5 mg/dL).I am over 18 and have a detectable tumor larger than 1 cc.I do not have any serious illnesses that can't be managed with treatment.I am able to care for myself and engage in normal activities.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)
- Group 2: Cohort 2: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been approved for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting patients as of May 1st 2023; the study was initially posted on April 11th 2023. The researchers are looking for 40 participants from a single location."
Answered by AI
Are there remaining slots for participants in this experiment?
"Affirmative. Clinicaltrials.gov registers that the trial, which was initially made available on April 11th of 2023, is still recruiting patients to participate. 40 individuals are required from 1 medical centre."
Answered by AI
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