Recruiting
Phase 1

Hyperpolarized Carbon C 13 Pyruvate

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03830151

Conditions

Primary Brain Neoplasm

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Magnetic Resonance Spectroscopic Imaging

Study Details

Brief 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.

Conditions

Primary Brain Neoplasm

Study ID

NCT03830151

Start date

May 16, 2019

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Healthy volunteers will be screened using same process but will otherwise not be subject to other selection criteria.
  • The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.
  • Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: • electronically, magnetically, and mechanically activated implants • ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostatic clips in the central nervous system (CNS) or body • cochlear implants • other pacemakers, e.g., for the carotid sinus • insulin pumps and nerve stimulators • non-MR safe lead wires • prosthetic heart valves (if dehiscence is suspected) • non-ferromagnetic stapedial implants • pregnancy • claustrophobia that does not readily respond to oral medication
  • Prior brain tumor treatment, including surgical resection, radiation therapy or chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the patient from participation. Remote history (> 6month) of non-CNS malignancy in remission, without evidence of current/ prior brain metastasis, will also not disqualify patient from participating.
  • History of cardiac arrhythmia

Study Design

Enrollment

13 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Given IV

Magnetic Resonance Spectroscopic Imaging

Undergo MRSI

Primary outcome measure

  • Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Dawid Schellingerhout

713-794-5673dawid.schellingerhout@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dawid Schellingerhout

713-794-5673

Principal Investigator:

Dawid Schellingerhout

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-16.