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Hyperpolarized C 13 Pyruvate Imaging for Brain Cancer

Phase 1

Recruiting

Led By Dawid Schellingerhout

Research Sponsored by M.D. Anderson Cancer Center

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 up to 1 year

Awards & highlights

Study Summary

This trial is testing a new imaging agent to see if it can help diagnose glioma, a type of brain tumor.

Who is the study for?

This trial is for adults over 18 with suspected or confirmed primary brain tumors who are candidates for tumor removal surgery. They must be able to undergo MRI scans and have a kidney function test (GFR) above 60. People with pacemakers, metal in their body, previous brain tumor treatments, or certain heart conditions cannot join.Check my eligibility

What is being tested?

Researchers are testing an imaging agent called hyperpolarized carbon C 13 pyruvate used before an advanced MRSI scan to see if it helps diagnose glioma more accurately in patients with brain tumors.See study design

What are the potential side effects?

Potential side effects of the imaging agent and MRSI scan may include discomfort during the procedure and reactions related to contrast agents used for those with moderate renal failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data

Secondary outcome measures

Genomic findings

Ki-67 quantitation

MR imaging findings

+3 more

Side effects data

From 2019 Phase 1 trial • 9 Patients • NCT03565367

33%

Anosmia

33%

Dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Healthy Volunteers

Known CNS Malignancy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (carbon C 13 pyruvate, MRSI)Experimental Treatment2 Interventions

Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperpolarized Carbon C 13 Pyruvate

2018

Completed Phase 1

~10

Magnetic Resonance Spectroscopic Imaging

2012

Completed Phase 1

~430

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,654 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,789 Total Patients Enrolled

Dawid SchellingerhoutPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

75 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently open to participants?

"Yes, according to clinicaltrials.gov this medical trial commenced on May 16th 2019 and was last amended November 16th 2022. At present 13 individuals are being sought out across a single recruitment site."

Answered by AI

Has the FDA accepted Hyperpolarized Carbon C 13 Pyruvate as a safe and efficacious treatment?

"Hyperpolarized Carbon C 13 Pyruvate has a score of 1 due to its Phase 1 designation, indicating that there is restricted data validating both safety and efficacy."

Answered by AI

What is the aggregate amount of participants currently enrolled in this trial?

"Affirmative. According to the details found on clinicaltrials.gov, this medical trial was initially published on May 16th 2019 and is presently recruiting participants at one place of treatment. A total of 13 patients are needed for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors

2019. "Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03830151.

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