Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation

Who is this study for? Patients with brain tumors
What treatments are being studied? Hyperpolarized Carbon C 13 Pyruvate+Magnetic Resonance Spectroscopic Imaging
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Written informed consent will be obtained from each participants including healthy volunteers.

• Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria.

• All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial

• Patient is \>18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.

• Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.

• Patient is able to understand and give consent to participation in the study.

• Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging.

• Patient has a GFR \> 60. In patients with moderate renal failure (GFR 30-60), an alternate injection with 2 times half-dose multihance (gadobenate dimeglumine) or gadovist (gadobutrol) will be considered, if a contrast exam is deemed clinically necessary.

• Specifically for this Study: Patient is willing to give signed informed consent for C13-Pyruvate MR Spectroscopy.

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Dawid Schellingerhout
dawid.schellingerhout@mdanderson.org
713-794-5673
Time Frame
Start Date: 2019-05-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 13
Treatments
Experimental: Diagnostic (carbon C 13 pyruvate, MRSI)
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov