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

Last updated: January 16, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

Gliomas

Treatment

Hyperpolarized Carbon C 13 Pyruvate

Magnetic Resonance Spectroscopic Imaging

Clinical Study ID

NCT03830151
2018-0902
P30CA016672
2018-0902
NCI-2019-00007
  • Ages > 19
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  • Healthy volunteers will not have contra-indications to MR scanning, but willotherwise 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 tocomplete all required visits and evaluations. The pediatric population has adifferent disease profile from the glioma patients we hope to recruit. To reduceheterogeneity 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 orpreviously 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), analternate injection with 2 times half-dose multihance (gadobenate dimeglumine) orgadovist (gadobutrol) will be considered, if a contrast exam is deemed clinicallynecessary.

  • Specifically for this Study: Patient is willing to give signed informed consent forC13-Pyruvate MR Spectroscopy.

Exclusion

Exclusion Criteria:

  • Healthy volunteers will be screened using same process but will otherwise not besubject to other selection criteria.

  • The patient is found to have unfavorable anatomy to indicate that stereotacticbiopsy could not be safely performed.

  • Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or otherconditions that are not MR safe, which include but are not limited to: •electronically, magnetically, and mechanically activated implants • ferromagnetic orelectronically operated active devices like automatic cardioverter defibrillatorsand cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostaticclips in the central nervous system (CNS) or body • cochlear implants • otherpacemakers, 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 notreadily respond to oral medication

  • Prior brain tumor treatment, including surgical resection, radiation therapy orchemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify thepatient from participation. Remote history (> 6month) of non-CNS malignancy inremission, without evidence of current/ prior brain metastasis, will also notdisqualify patient from participating.

  • History of cardiac arrhythmia

Study Design

Total Participants: 13
Treatment Group(s): 2
Primary Treatment: Hyperpolarized Carbon C 13 Pyruvate
Phase: 1
Study Start date:
May 16, 2019
Estimated Completion Date:
December 31, 2025

Study Description

PRIMARY OBJECTIVES:

I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.

SECONDARY OBJECTIVES:

I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate (kpl) values and Ki-67 quantitation in the tumor.

II. To compare kpl values between tumor and normal brain within patient. III. To assess the association between kpl values and pathology results, including conventional, diffusion, perfusion, and permeability imaging.

IV. To assess the association between kpl values and magnetic resonance (MR) imaging findings.

V. To assess the association between kpl values and genomic findings, including methylation, ribonucleic acid [RNA], and deoxyribonucleic acid [DNA]).

OUTLINE:

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

After completion of study, patients are followed up for 1 day.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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