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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-00007 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0902 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (carbon C 13 pyruvate, MRSI) | Experimental | Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized Carbon C 13 Pyruvate | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data | The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Ki-67 quantitation | 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. | Up to 1 year |
| Tumor kpl values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawid Schellingerhout | Contact | 713-794-5673 | dawid.schellingerhout@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Dawid Schellingerhout | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Magnetic Resonance Spectroscopic Imaging | Procedure | Undergo MRSI |
|
|
Will compare with normal brain kpl values. Linear mixed models will be used. |
| Up to 1 year |
| Normal brain kpl values | Will compare with tumor kpl values. Linear mixed models will be used. | Up to 1 year |
| Pathology results | Correlation with kpl values will be determined through generalized linear mixed models. | Up to 1 year |
| MR imaging findings | Correlation with kpl values will be determined through generalized linear mixed models. | Up to 1 year |
| Genomic findings | Correlation with kpl values will be determined through generalized linear mixed models. | Up to 1 year |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |