Hyperpolarized MRI for CNS Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen by James Rubenstein, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: James Rubenstein

Must be taking: Methotrexate, Temozolomide, Rituximab

Disqualifiers: Congestive heart failure, Other cancer, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I trial evaluates the feasibility of using hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing patients with primary central nervous system lymphoma. This trial aims to see whether MRI using hyperpolarized carbon-13 pyruvate is safe and useful for detecting central nervous system lymphoma and evaluating response to treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are in Cohort 2, you will receive specific treatments like high-dose methotrexate, temozolomide, and rituximab.

What data supports the effectiveness of the treatment Hyperpolarized 13C pyruvate MRI for CNS Lymphoma?

Research shows that Hyperpolarized 13C pyruvate MRI can track tumor metabolism and detect treatment responses in brain tumors, as seen in studies with glioma models and pediatric brain tumors. This suggests it could be useful for evaluating CNS lymphoma by providing detailed metabolic information and early detection of treatment effects. ^{1 2 3 4 5}

Is hyperpolarized 13C pyruvate MRI safe for humans?

Hyperpolarized 13C pyruvate MRI has been used safely in clinical studies, including imaging in healthy human volunteers, without the use of ionizing radiation, suggesting it is generally safe for humans. ^{1 2 3 4 6}

How is the treatment Hyperpolarized pyruvate (13C) unique for CNS Lymphoma?

Hyperpolarized pyruvate (13C) is unique because it allows for real-time imaging of tumor metabolism using MRI, providing detailed insights into how the tumor processes energy. This approach is different from traditional treatments as it offers a non-invasive way to monitor tumor activity and response to therapy, potentially leading to more personalized treatment plans. ^{2 3 4 5 7}

Research Team

James Rubenstein, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over 18 with primary central nervous system lymphoma, who have a life expectancy of more than 12 weeks. They must have measurable disease on MRI and adequate kidney function. It's not for those with significant medical illnesses, heart failure, other cancers within the last 3 years (except certain skin cancers or cervical carcinoma in-situ), pregnant or breastfeeding women, or anyone unable to follow study procedures.

Inclusion Criteria

Each participant must sign an institutional review board-approved informed consent document in accordance with federal and institutional guidelines. Patients must sign an authorization for release of their protected health information.

I have a confirmed primary CNS lymphoma with a lesion over 1cm visible on MRI.

My cancer is a type of non-Hodgkin lymphoma in the brain.

Exclusion Criteria

Subjects must be excluded from participating in this study if are not able to comply with study and/or follow-up procedures.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants receive hyperpolarized carbon C 13 pyruvate intravenously and undergo MRI at baseline

1 day

1 visit (in-person)

Treatment

Participants in Cohort 2 receive standard high-dose methotrexate, temozolomide plus rituximab therapy, followed by MRI imaging

Up to 4 months

Multiple visits (in-person) for chemotherapy and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for 2 years, every 6 months for the next 3 years, and then annually for the next 5 years

Up to 10 years

Regular follow-up visits

Treatment Details

Interventions

• Hyperpolarized pyruvate (13C) (Virus Therapy)
• Magnetic resonance imaging (MRI) (Procedure)

Trial Overview The trial is testing the safety and usefulness of a new type of MRI that uses hyperpolarized carbon C 13 pyruvate to diagnose CNS lymphoma and monitor treatment response. Participants will undergo this special imaging to see if it provides clear pictures of their condition.

Participant Groups

Group I: Cohort 2: Hyperpolarized pyruvate (13C) Experimental Treatment 2 Interventions

Newly diagnosed PCNSL participants with planned treatment of standard high-dose methotrexate,temozolomide plus rituximab (MT-R) regimen will receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRI at baseline and again after three cycles of of standard induction chemotherapy. An optional second HP 13C pyruvate injection and MRI acquisition will be offered on same day following completion of the first scan. Participants in Cohort 2 will also have option to undergo an additional imaging at a later time if the participant's cancer progresses.

Group II: Cohort 1: Hyperpolarized pyruvate (13C) Experimental Treatment 2 Interventions

Histologically proven relapsed PCNSL patients will receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRI at baseline. An optional second HP 13C pyruvate injection and MRI acquisition will be offered on same day following completion of the first scan.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, San Francisco San Francisco, CA

Who Is Running the Clinical Trial?

James Rubenstein

Lead Sponsor

Trials

3

Patients Recruited

70+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting response of rat C6 glioma tumors to radiotherapy using hyperpolarized [1- 13C]pyruvate and 13C magnetic resonance spectroscopic imaging. Day, SE., Kettunen, MI., Cherukuri, MK., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric spiral chemical shift imaging of hyperpolarized [2-(13) c]pyruvate in a rat c6 glioma model. Park, JM., Josan, S., Jang, T., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon-13 MRI in Breast Cancer. Woitek, R., Brindle, KM.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized [2-13C]pyruvate MR molecular imaging with whole brain coverage. Chung, BT., Kim, Y., Gordon, JW., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of Hyperpolarized 13C Metabolic Imaging in Pediatric Patients with Diffuse Intrinsic Pontine Glioma and Other CNS Cancers. Autry, AW., Park, I., Kline, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized MRI - An Update and Future Perspectives. Jørgensen, SH., Bøgh, N., Hansen, E., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Imaging of the Human Brain with Hyperpolarized 13C Pyruvate Demonstrates 13C Lactate Production in Brain Tumor Patients. Miloushev, VZ., Granlund, KL., Boltyanskiy, R., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Detecting response of rat C6 glioma tumors to radiotherapy using hyperpolarized [1- 13C]pyruvate and 13C magnetic resonance spectroscopic imaging. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Volumetric spiral chemical shift imaging of hyperpolarized [2-(13) c]pyruvate in a rat c6 glioma model. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon-13 MRI in Breast Cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Hyperpolarized [2-13C]pyruvate MR molecular imaging with whole brain coverage. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Pilot Study of Hyperpolarized 13C Metabolic Imaging in Pediatric Patients with Diffuse Intrinsic Pontine Glioma and Other CNS Cancers. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Hyperpolarized MRI - An Update and Future Perspectives. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Metabolic Imaging of the Human Brain with Hyperpolarized 13C Pyruvate Demonstrates 13C Lactate Production in Brain Tumor Patients. [2019]