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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00939 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01CA109767 | U.S. NIH Grant/Contract | View source | |
| R01CA273028 | U.S. NIH Grant/Contract | View source | |
| 2P50CA097257 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for evaluating tumor burden and detecting early response to therapy in participants with glioma.
II. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C data from the brain, one hundred participants with evidence of residual disease from a prior MRI examination will have hyperpolarized metabolic imaging after receiving one or two injections of hyperpolarized 13 C pyruvate. For participants who are willing to receive two injections, the 2nd injection will be used to assess reproducibility, evaluate the performance of new acquisition methods, or compare metabolism between [1-13C]pyruvate and [213C]pyruvate.
III. To establish the time course of changes in hyperpolarized pyruvate and lactate peaks on a voxel by voxel basis from the dynamic hyperpolarized data after the injection(s) of hyperpolarized 13C pyruvate. Twenty participants will be studied before and after treatment with treatment in order to determine the time course of delivery of 13C pyruvate and the location of maximum pyruvate and lactate or glutamate signals in normal brain and in the region of T2 hyperintensity (T2L).
IV. To evaluate if participants who receive treatment with standard radiation and temozolomide exhibit a reduction in hyperpolarized 13C lactate/pyruvate or 13C glutamate/pyruvate at post-radiation follow-up compared to their baseline scan. A second group of twenty participants will be studied at the time determined from the prior group to provide the maximum contrast between lactate/pyruvate or glutamate/pyruvate in the lesion versus normal brain.
OUTLINE: Participants are assigned to 1 of 2 cohorts.
COHORT I: Participants receive one or two hyperpolarized carbon C 13 pyruvate injections intravenously (IV) and undergo MRI.
COHORT II: Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of treatment.
After completion of study treatment, participants are followed for up to 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I (Hyperpolarized C13, MRI) | Experimental | Participants receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRI. The second hyperpolarized 13 C injection/imaging will be started approximately 15 to 60 minutes after the first injection for those who are willing to receive two 13 C injections |
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| Cohort II (Hyperpolarized C13, MRI) | Experimental | Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of cancer therapy given outside of this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized Carbon C 13 Pyruvate | Radiation | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Adverse events will be monitored from just before investigational medicinal product (IMP) administration until the end of study participation. Vital signs (blood pressure and heart rate only) will be recorded at baseline and 30 minutes post injection. For blood pressures and heart rate recorded after IMP administration, the following safety endpoints will be summarized for each part of the study: (1) The occurrence of changes from baseline, at each post-administration time point, greater than a pre-specified magnitude (20 mm Hg for systolic blood pressure, 10 mm Hg for diastolic blood pressure, 10 beats per minute for heart rate). (2) The occurrence of post-administration values outside the normal limits. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0 | Up to 24 months |
| Peak lactate/pyruvate ratio in brain tissue | The lactate/pyruvate ratio and/or glutamate/pyruvate will be compared in tumor versus normal appearing brain tissue. Comparisons will be made using a Wilcoxon signed rank test. | Up to 24 months |
| Peak lactate/pyruvate ratio in (13C) pyruvate scan | The lactate/pyruvate ratio and/or glutamate/pyruvate from baseline will be compared to the ratio on the post-radiation therapy (RT) repeat scan. Comparisons will be made using a Wilcoxon signed rank test. | Up to 4 months. |
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Inclusion Criteria:
For Participants in Cohort 1: Suspected or histologically proven glioma who have evidence of evaluable disease based on a prior magnetic resonance (MR) scan.
For Participants in Cohort 2: Histologically proven glioma who will be undergoing treatment.
To be included in the study all subjects must also meet the following criteria:
Exclusion Criteria:
1. Participants must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Ma | Contact | (415) 514-4418 | Wendy.Ma@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Susan Chang, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32623139 | Background | Autry AW, Gordon JW, Chen HY, LaFontaine M, Bok R, Van Criekinge M, Slater JB, Carvajal L, Villanueva-Meyer JE, Chang SM, Clarke JL, Lupo JM, Xu D, Larson PEZ, Vigneron DB, Li Y. Characterization of serial hyperpolarized 13C metabolic imaging in patients with glioma. Neuroimage Clin. 2020;27:102323. doi: 10.1016/j.nicl.2020.102323. Epub 2020 Jun 24. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2024 | Nov 15, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Radiation Therapy | Radiation | Undergo radiation therapy for cancer outside of this study. |
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| Chemotherapy | Drug | Undergo chemotherapy for cancer outside of this study. |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D055585 | Physical Phenomena |