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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-05550 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| 5R21EB030899-02 | U.S. NIH Grant/Contract | View source | |
| 2P01CA118816-11A1 | U.S. NIH Grant/Contract | View source | |
| 2P01CA118816-16 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
| General Electric | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior
Primary Objective:
I. To assess the feasibility of hyperpolarized 13C MR imaging as a new and unique tool in the characterization of aggressive tumor behavior in participants with meningioma.
Secondary Objectives:
I. To define the most appropriate parameters for obtaining hyperpolarized 13C data from meningioma patients with a run-in study to optimize spatial and temporal resolution and coverage by detecting signal amplitudes and time dynamics.
II. To measure tumor pyruvate-to-lactate, pyruvate-to-alanine, and pyruvate-to-bicarbonate conversion by 13C pyruvate MR imaging in participants with meningioma planning to undergo surgical resection within 4 weeks, using parameters.
Outline:
Participants will receive a single imaging procedure using HP 13C pyruvate. Participants will then be followed-up for 30 days after completion of the study or until voluntary withdrawal or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging | Experimental | Participants will receive a single research MR imaging using HP 13C pyruvate, intravenously injected at a rate of 5 ml/second followed by a 20-ml saline flush at 5 ml/second. Safety monitoring, including vital signs and symptom monitoring will be performed for 30 minutes after dosing is completed, 1 to 3 days after dosing, and up to 30 days post scanning procedure. During the follow-up period, study personnel will obtain clinical data from the participants' medical records. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized carbon C 13 pyruvate | Drug | Given Intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who complete 13C pyruvate MR imaging. | All participants who are enrolled in the study and receive any amount of hyperpolarized 13C pyruvate will be included in the primary outcome analysis. The proportion of participants who complete hyperpolarized 13C pyruvate MR imaging will be reported. If the proportion is greater than 0.7, hyperpolarized 13C MR imaging will be determined to be feasible. | Day of MR imaging (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-lactate cell metabolism | Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yields the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-lactate will be identified. | Day of MR imaging (1 day) |
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Inclusion Criteria:
Known (histopathologically confirmed) or presumed meningioma based on imaging with measurable disease on MRI that shows gadolinium enhancement (at least one cm diameter) intracranially (e.g., not confined to skull base alone).
a. Thirty of the participants plan to have surgical resection within 4 weeks
Participants cannot have contraindication to MRI examinations.
Age >=18 years.
Have a life expectancy of >12 weeks.
Karnofsky Performance Status > 60%.
Participants must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. This test must be performed within 60 days prior to hyperpolarized imaging scan.
Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.
Participants must sign an authorization for the release of their protected health information.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Ma | Contact | (415) 514-4418 | Wendy.Ma@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Javier Villanueva-Meyer, 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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| ID | Term |
|---|---|
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Magnetic Resonance Image (MRI) | Procedure | Imaging procedure |
|
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| Saline | Other | Given IV |
|
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| Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-alanine cell metabolism | Five initial patients will be evaluated to establish the spatial, temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-alanine will be identified. | Day of MR imaging (1 day) |
| Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-bicarbonate cell conversion | Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-bicarbonate conversion will be identified. | Day of MR imaging (1 day) |
| Mean of pyruvate-to-lactate | The mean and standard deviations of pyruvate-to-lactate ratio will be reported. | Day of MR imaging (1 day) |
| Mean of pyruvate-to-alanine | The mean and standard deviations of pyruvate-to-alanine ratio will be reported. | Day of MR imaging (1 day) |
| Mean of pyruvate-to-bicarbonate conversion | The mean and standard deviations of pyruvate-to-bicarbonate conversion rate will be reported. | Day of MR imaging (1 day) |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D017670 |
| Sodium Compounds |