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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data
Secondary study objectives
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%
0%
Study treatment Arm
Healthy Volunteers
Known CNS Malignancy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,104 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,334 Total Patients Enrolled
Dawid SchellingerhoutPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
67 Total Patients Enrolled
~2 spots leftby Dec 2025
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