What side effects are associated with this type of intervention?

Common treatments for adult gliomas, including surgery, radiation therapy, and chemotherapy, have various side effects. Radiation therapy can cause fatigue, hair loss, skin changes, and cognitive decline. Chemotherapy, such as temozolomide, often leads to nausea, vomiting, fatigue, and myelosuppression. Targeted therapies like bevacizumab may result in hypertension, proteinuria, and thromboembolic events. Treatments for IDH mutant gliomas may have unique responses, potentially affecting the side effect profile.

What prior FDA approvals exist?

FDA-approved treatments for adult gliomas include temozolomide, which is an oral alkylating agent used in combination with radiotherapy for newly diagnosed glioblastoma multiforme (GBM) and as a monotherapy for recurrent GBM. Bevacizumab, an anti-VEGF antibody, is approved for recurrent GBM. For IDH mutant gliomas, there are no specific FDA-approved treatments targeting the IDH mutation, but ongoing research and trials, such as those involving Hyperpolarized Carbon-13 Alpha-Ketoglutarate, aim to enhance imaging and treatment efficacy for these specific mutations.

What other types of research exist?

Promising alternatives for adult glioma patients include: 1) Advanced MRI techniques such as diffusion-weighted imaging and MR spectroscopy, which can provide detailed metabolic and physiological information. 2) PET/CT imaging with novel tracers like 18F-fluciclovine, which has shown efficacy in detecting recurrent tumors. 3) Targeted therapies such as EGFR and ALK inhibitors, which have demonstrated CNS penetration and effectiveness in specific genetic subtypes of gliomas. 4) Boron Neutron Capture Therapy (BNCT), which is being evaluated for its potential to deliver high-dose radiation selectively to tumor cells.

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Metabolic Imaging Agent

HP C13-aKG MRI for Brain Tumor

Q: What is the mechanism of action of this treatment?

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of imaging (1 day) for reporting.

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 more

Awards & 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.

Do I qualify?Apply below to find out

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: Mycobacterium avium subspecies paratuberculosis 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.