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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
No Placebo-Only Group
Summary
This trial uses a special imaging dye to help doctors see brain tumors more clearly on MRI scans. It focuses on patients with a specific type of brain tumor that may not respond well to typical treatments. The dye makes the tumors more visible, aiding in better measurement and understanding.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for adult gliomas, particularly IDH-mutant gliomas, include chemotherapy, radiation therapy, and advanced imaging techniques. Chemotherapy agents like temozolomide work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate.
Radiation therapy uses high-energy beams to destroy cancer cells and shrink tumors. Advanced imaging techniques, such as Hyperpolarized Carbon-13 Alpha-Ketoglutarate (HP 13C-aKG), enhance the visualization of tumor metabolism and burden, allowing for more precise treatment planning and monitoring.
These treatments are crucial for adult glioma patients as they target the tumor cells directly, improve the accuracy of diagnosis and treatment, and potentially enhance the overall prognosis by enabling personalized treatment strategies.
Baseballs, tennis balls, livestock farm manure, the IDH1 mutation, endothelial cell proliferation and hypoxic pseudopalisading (granulomatous) necrosis: <i>Mycobacterium avium</i> subspecies <i>paratuberculosis</i> and the epidemiology, cellular metabolism and histology of diffuse gliomas, including glioblastoma.Glutamate Is a Noninvasive Metabolic Biomarker of IDH1-Mutant Glioma Response to Temozolomide Treatment.
Baseballs, tennis balls, livestock farm manure, the IDH1 mutation, endothelial cell proliferation and hypoxic pseudopalisading (granulomatous) necrosis: <i>Mycobacterium avium</i> subspecies <i>paratuberculosis</i> and the epidemiology, cellular metabolism and histology of diffuse gliomas, including glioblastoma.Glutamate Is a Noninvasive Metabolic Biomarker of IDH1-Mutant Glioma Response to Temozolomide Treatment.
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Who is running the clinical trial?
Robert Bok, MD, PhDLead Sponsor
2 Previous Clinical Trials
226 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,943 Previous Clinical Trials
41,024,661 Total Patients Enrolled
Susan Chang, MDPrincipal InvestigatorUniversity of California, San Francisco
6 Previous Clinical Trials
246 Total Patients Enrolled
Media Library
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.