Hyperpolarized 13C Pyruvate Imaging for Glioblastoma

Overseen By Wendy Ma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Susan Chang

Must be taking: Temozolomide

Disqualifiers: HIV, Heart failure, Recent cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method to aid in treating glioblastoma, a type of brain cancer. The trial tests the effectiveness of adding hyperpolarized 13C pyruvate to standard MRI scans, aiming to help doctors make better treatment decisions. Participants may qualify if they have been diagnosed with glioblastoma, either newly or recurrent, and are about to start or have started standard treatments like radiation or surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that significant medical illnesses must be controlled with appropriate therapy, so it's best to discuss your specific medications with the study team.

What prior data suggests that hyperpolarized 13C pyruvate imaging is safe for glioblastoma patients?

Research shows that hyperpolarized 13C pyruvate is generally safe for humans. Studies have demonstrated its safety, particularly in imaging techniques. For patients with glioblastoma, previous tests with this substance have not raised major safety concerns.

Safety data supports its use. Patients have tolerated the specific concentration of hyperpolarized 13C pyruvate injected in these studies well. In simpler terms, recipients did not experience significant side effects.

Additionally, hyperpolarized 13C pyruvate has been used safely in other imaging studies, such as those involving the prostate. These findings suggest a low risk of serious side effects, making it a promising option for imaging in glioblastoma patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized 13C pyruvate imaging because it offers a novel way to visualize brain tumors like glioblastoma with high precision. Unlike standard treatment options such as radiation therapy, temozolomide, and surgical resection, which focus on directly treating the tumor, this technique enhances imaging by using hyperpolarized 13C pyruvate. This compound allows real-time tracking of metabolic activity in tumor cells, potentially leading to better understanding and monitoring of how tumors respond to treatments. By providing detailed metabolic insights, this approach could revolutionize how we assess treatment effectiveness and tailor therapies for patients.

What evidence suggests that hyperpolarized 13C pyruvate imaging is effective for glioblastoma?

Research has shown that a special imaging technique using hyperpolarized 13C pyruvate provides detailed pictures of how glioblastoma tumors use energy. This trial will evaluate the imaging method in different patient groups. In Cohort 1, patients with newly diagnosed glioblastoma will undergo hyperpolarized 13C pyruvate imaging before and after standard treatment with radiation and temozolomide. In Cohort 2, patients with recurrent glioblastoma undergoing surgical resection will receive imaging before surgery. In Cohort 3, patients with recurrent glioblastoma receiving standard treatment will have imaging at multiple time points. Studies have found that this method can detect changes in the tumor's energy use, especially after treatments like surgery or radiation. By using this technique, doctors can see active tumors more clearly, potentially improving treatment planning. Early evidence suggests that this imaging can be a valuable tool for assessing treatment effectiveness in glioblastoma patients. ^{5 6 7 8 9}

Who Is on the Research Team?

Susan Chang, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed or recurrent glioblastoma who are undergoing standard treatment. They must have a life expectancy of at least 16 weeks, good performance status, and adequate kidney function. Excluded are those with significant medical illnesses, recent heart issues, known HIV positivity, pregnancy or breastfeeding women, and anyone unable to follow the study procedures.

Inclusion Criteria

My kidney function is good, with creatinine levels below 1.5 mg/dL.

My gender or race does not affect my eligibility for this study.

Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation

Exclusion Criteria

Subjects unable to comply with study and/or follow-up procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Treatment Preparation

Participants receive MR examination with hyperpolarized 13C pyruvate injection for research imaging before standard treatment or surgery

1-2 weeks

1-3 visits (in-person) depending on group assignment

Treatment

Participants undergo standard treatment with radiation and chemotherapy or surgical resection

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-radiation follow-up scans

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 13C Pyruvate

Trial Overview The trial tests a new type of metabolic imaging using hyperpolarized 13C pyruvate in combination with standard MR imaging. It aims to see if this can help make better treatment decisions for patients with glioblastoma by providing more detailed information about how treatments are working.

How Is the Trial Designed?

Group I: Cohort 3: Recurrent- Standard Treatment Experimental Treatment 1 Intervention

This arm is for patients with histologically proven recurrent suspected glioblastoma who will undergo standard treatment for the recurrence. Patients will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at three time points: prior to treatment (baseline), approximately 7-14 days after the initiation of treatment, and 6-8 weeks after the initiation of treatment.

Group II: Cohort 2: Recurrent- Standard Surgical Resection Experimental Treatment 1 Intervention

This arm is for patients with histologically proven recurrent suspected glioblastoma who will receive surgical resection for the recurrence. Patients will receive one injection of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at one time point: before surgery.

Group III: Cohort 1: Newly Diagnosed- Standard Treatment Experimental Treatment 1 Intervention

This arm is for patients with histologically proven newly diagnosed glioblastoma who will undergo standard treatment with radiation therapy (RT) and temozolomide (TMZ). Patients will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at two time points: before receiving standard treatment with RT/TMZ and at the first post-radiation follow-up scan (8 weeks later).

Who Is Running the Clinical Trial?

Susan Chang

Lead Sponsor

Trials

5

Recruited

520+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9360994/

Imaging Glioblastoma Metabolism ... Carbon 13 (13C) MRI following injection of hyperpolarized 13C-labeled pyruvate can be used to characterize glioblastoma metabolism and changes ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04019002

Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in ... The purpose of this study is to evaluate whether new metabolic imaging will be useful to physicians and patients with glioblastoma for making treatment ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213158220301601

Characterization of serial hyperpolarized 13C metabolic ... With regard to HP-13C imaging, the data suggest that [1-13C]pyruvate extravasation is reduced as a result of vascular changes induced by bevacizumab, which ...

4. aacrjournals.org aacrjournals.org/cancerres/article/78/14/3755/631786/Metabolic-Imaging-of-the-Human-Brain-with

Metabolic Imaging of the Human Brain with Hyperpolarized 13 ... Hyperpolarized pyruvate MRI enables metabolic imaging in the brain and can be a quantitative biomarker for active tumors.

5. academic.oup.com academic.oup.com/noa/article/3/1/vdab092/6310832

Preoperative imaging of glioblastoma patients using ... This study demonstrates the feasibility of using 13C MR imaging with hyperpolarized pyruvate in the preoperative evaluation of glioblastoma and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6490043/

Hyperpolarized 13C MRI: State of the Art and Future Directions Preliminary data have also demonstrated that HP [1-13C]pyruvate MRI provides reproducible measurements of metabolic changes in the prostates of patients who ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1053811923005013

Hyperpolarized [2–13C]pyruvate MR molecular imaging ... Hyperpolarized (HP) 13 C Magnetic Resonance Imaging (MRI) was applied for the first time to image and quantify the uptake and metabolism of [2– 13 C]pyruvate ...

8. dctd.cancer.gov dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/13c-pyruvate-ib.pdf

Hyperpolarized Pyruvate (13C) Injection safety pharmacology data support adequate safety of Hyperpolarized Pyruvate (13C) Injection containing 250 mM [1-13C]pyruvate and no-more-than 3 µM of ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mrm.29875

Current methods for hyperpolarized [1‐13C]pyruvate MRI ... The overall safety record of HP 13C-pyruvate has been very strong ... hyperpolarized [1-13C]pyruvate MRI data from patients with glioma.