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Hyperpolarized MRI for Brain Tumor

Phase 1

Recruiting

Led By Susan Chang, MD

Research Sponsored by Susan Chang

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be > 18 years old and with a life expectancy > 12 weeks.

Patients must have a Karnofsky performance status of ≥ 60.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects of a new MRI that may help diagnose glioma.

Who is the study for?

This trial is for adults over 18 with a life expectancy of more than 12 weeks and diagnosed with glioma, who are not HIV-positive, pregnant or breastfeeding. Participants must have adequate kidney function, no severe heart failure or recent heart attacks, and no other cancers except certain skin cancers or cervical carcinoma in-situ unless in remission for at least 3 years.

What is being tested?

The trial tests the safety of using hyperpolarized carbon C 13 pyruvate MRI to diagnose gliomas. It involves patients already scheduled for standard treatment with radiation and temozolomide (Cohort 2), as well as those with evaluable disease based on prior MR scans (Cohort 1).

What are the potential side effects?

While specific side effects are not listed, the study aims to identify any associated with hyperpolarized carbon C 13 pyruvate MRI. Potential risks may be related to the imaging process itself or reactions to the substance used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old and expected to live more than 12 weeks.

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I am mostly able to care for myself but may need occasional help.

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I haven't had a heart attack or unstable chest pain in the last year.

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I have no cancer history except for non-melanoma skin cancer or cervical carcinoma in-situ, or I've been cancer-free and off treatment for 3 years.

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My heart functions well enough not to limit my physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Peak lactate/pyruvate ratio in (13C) pyruvate scan

Peak lactate/pyruvate ratio in brain tissue

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 II (Hyperpolarized C13, MRI)Experimental Treatment4 Interventions

Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of cancer therapy given outside of this study.

Group II: Cohort I (Hyperpolarized C13, MRI)Experimental Treatment2 Interventions

Participants receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRI. The second hyperpolarized 13 C injection/imaging will be started approximately 15 to 60 minutes after the first injection for those who are willing to receive two 13 C injections

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Hyperpolarized Carbon C 13 Pyruvate

2018

Completed Phase 1

~10