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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-08761 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01CA262630 | U.S. NIH Grant/Contract | View source | |
| P50CA097257-22 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
| Sigma-Aldrich | UNKNOWN |
| Phillips-Medisize | UNKNOWN |
| National Cancer Institute (NCI) |
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This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans.
III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan.
OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility.
COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT) | Experimental | Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist |
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| Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI) | Experimental | Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. |
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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 |
|---|---|---|
| Number of treatment-emergent adverse events (AEs) | Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics. | Up to 4 years |
| Peak lactate/pyruvate | The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported. | Up to 4 years |
| Peak bicarbonate/pyruvate | The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported. | Up to 4 years |
| Change in peak lactate/pyruvate between scans | The change in peak lactate/pyruvate between scans will be reported. | Baseline up to 4 years |
| Change in peak bicarbonate/pyruvate between scans | The change in peak bicarbonate/pyruvate between scans will be reported. | Baseline up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Ma | Contact | 877-827-3222 | cancertrials@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Susan M 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 |
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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 | Jul 23, 2024 | Oct 7, 2024 |
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| NIH |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Magnetic Resonance Spectroscopic Imaging | Procedure | Undergo MRSI |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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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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