Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate (kpl) values and Ki-67 quantitation in the tumor.
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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.
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To assess the association between kpl values and magnetic resonance (MR) imaging findings.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Hyperpolarized Carbon C 13 Pyruvate
Given IV
Other Names:
Procedure: Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- Pathology results [Up to 1 year]
Correlation with kpl values will be determined through generalized linear mixed models.
- MR imaging findings [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent will be obtained from each participants including healthy volunteers.
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Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria.
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All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial
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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.
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Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.
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Patient is able to understand and give consent to participation in the study.
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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.
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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.
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Specifically for this Study: Patient is willing to give signed informed consent for C13-Pyruvate MR Spectroscopy.
Exclusion Criteria:
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Healthy volunteers will be screened using same process but will otherwise not be subject to other selection criteria.
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The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.
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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
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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.
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History of cardiac arrhythmia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Dawid Schellingerhout, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2018-0902
- NCI-2019-00007
- 2018-0902
- P30CA016672