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

Phase 1

Recruiting

• Conditions: Primary Brain Neoplasm
• Interventions: Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging

• Registration Number: NCT03830151
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-05-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (carbon C 13 pyruvate, MRSI)	Magnetic Resonance Spectroscopic Imaging	Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
Diagnostic (carbon C 13 pyruvate, MRSI)	Hyperpolarized Carbon C 13 Pyruvate	Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.

Primary Outcome Measures

Name	Time	Method
Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data	Up to 1 year	The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.

Secondary Outcome Measures

Name	Time	Method
Tumor kpl values	Up to 1 year	Will compare with normal brain kpl values. Linear mixed models will be used.
Normal brain kpl values	Up to 1 year	Will compare with tumor kpl values. Linear mixed models will be used.
MR imaging findings	Up to 1 year	Correlation with kpl values will be determined through generalized linear mixed models.
Ki-67 quantitation	Up to 1 year	Spearman's rank correlation will be used to assess the association between kpl values and Ki-67 if the samples are assumed to be independent. Otherwise, intraclass correlation coefficient (ICC) of random effects models will be used.
Pathology results	Up to 1 year	Correlation with kpl values will be determined through generalized linear mixed models.
Genomic findings	Up to 1 year	Correlation with kpl values will be determined through generalized linear mixed models.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States