Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma

NCT ID: NCT04019002

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2025-09-30

Brief Summary

The purpose of this study is to evaluate whether new metabolic imaging will be useful to physicians and patients with glioblastoma for making treatment decisions and seeing how well various types of treatment work. The goal is to improve the way patient care is managed in the future.

If you chose to be in this study, you will be receiving novel magnetic resonance (MR) metabolic imaging with standard MR imaging. The research component includes an injection of an investigational agent, called hyperpolarized 13C pyruvate, to obtain dynamic metabolic imaging.

Detailed Description

The new metabolic imaging will use hyperpolarized 13C pyruvate, which allows for pictures of the brain that we won't be able to get with standard imaging. Hyperpolarized 13C pyruvate has not been approved for use by the Food and Drug Administration (FDA) and is available for research only. This investigational agent is a non-radioactive isotope of carbon.

There are three groups in this study. Assignment to a study group depends on the status of your disease and the type of treatment you will be receiving.

Subjects in Group 1 will have two MR examination time points. Each time point includes a hyperpolarized 13C pyruvate injection for research imaging as well as standard MR. The MR examinations will occur before receiving standard of care treatment with radiation and chemotherapy, and at the first post-radiation follow-up scan.

Subjects in Group 2 will have one MR examination time point with hyperpolarized 13C pyruvate injection for research and standard MR. This MR examination occurs before surgery.

Subjects in Group 3 will have three MR examination time points. Each time point includes a hyperpolarized 13C pyruvate injection for research imaging as well as standard MR. The MR examinations will occur prior to initiating therapy (baseline), at approximately 7-14 days after initiation of therapy, and 6-8 weeks after the initiation of therapy.

Conditions

Glioblastoma Multiforme (GBM)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort 1: Newly Diagnosed- Standard Treatment

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).

Group Type: EXPERIMENTAL

Hyperpolarized 13C Pyruvate

Intervention Type: DRUG

Given at 0.43 milliliters/kilogram body weight of a 250 millimolar (mM) solution via intravenous injection over a period of about 1 minute once prior to each research magnetic resonance imaging procedure.

Cohort 2: Recurrent- Standard Surgical Resection

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 Type: EXPERIMENTAL

Hyperpolarized 13C Pyruvate

Intervention Type: DRUG

Given at 0.43 milliliters/kilogram body weight of a 250 millimolar (mM) solution via intravenous injection over a period of about 1 minute once prior to each research magnetic resonance imaging procedure.

Cohort 3: Recurrent- Standard Treatment

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 Type: EXPERIMENTAL

Hyperpolarized 13C Pyruvate

Intervention Type: DRUG

Given at 0.43 milliliters/kilogram body weight of a 250 millimolar (mM) solution via intravenous injection over a period of about 1 minute once prior to each research magnetic resonance imaging procedure.

Interventions

Hyperpolarized 13C Pyruvate

Given at 0.43 milliliters/kilogram body weight of a 250 millimolar (mM) solution via intravenous injection over a period of about 1 minute once prior to each research magnetic resonance imaging procedure.

Intervention Type: DRUG

Other Intervention Names

HP-13C

Eligibility Criteria

Inclusion Criteria

• Cohort 1: Histologically proven newly diagnosed glioblastoma multiforme (GBM) who will undergo standard of treatment with radiation therapy (RT) and temozolomide (TMZ).
• Cohort 2: Histologically proven recurrent suspected GBM who will receive surgical resection for the recurrence.
• Cohort 3: Histologically proven recurrent suspected GBM who will undergo standard treatment for the recurrence.
• Patients must be >/= 18 years old and with a life expectancy > 16 weeks.
• Patients must have a Karnofsky performance status of ≥ 70.
• Patients must have adequate renal function: creatinine < 1.5 mg/dL before imaging. These tests must be performed within 60 days prior to Hyperpolarized Imaging scan.
• Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent.
• Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
• Patients must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
• This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
• Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.
• Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
• Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Susan Chang

OTHER

Sponsor Role: lead

Responsible Party

Susan Chang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susan Chang, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2P50CA097257

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2019-07406

Identifier Type: REGISTRY

Identifier Source: secondary_id

19105

Identifier Type: -

Identifier Source: org_study_id