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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01122 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB-39845 | Other Identifier | Stanford IRB | |
| BRN0036 | Other Identifier | OnCore | |
| R01CA245097-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.
PRIMARY OBJECTIVES:
I. To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized [1-13C] pyruvate) for magnetic resonance imaging (MRI).
II. To assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after IV injection of hyperpolarized [1-13C] pyruvate.
OUTLINE:
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo magnetic resonance spectroscopic imaging (MRSI) over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
After completion of study, participants are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes. |
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| Known CNS Malignancy | Experimental | Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadolinium | Other | gadolinium enhanced MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 2 or Higher Toxicities | The measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases) | 2 days (+/-2) after the scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue | The outcome is defined as the number of participants with hyperpolarized carbon C 13 pyruvate magnetic resonance signal detection above background noise level of both lactate and bicarbonate in all tumors screened. | Imaging timepoint (up to 15 minutes to obtain scan) |
Inclusion Criteria:
Exclusion Criteria:
Refusal to have an IV placed for injection
Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement
Total bilirubin > 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN
Gamma-glutamyltransferase (GGT) > 2.5 x ULN
Pregnant or breast-feeding
Cardiovascular risk, including:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Recht | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes. |
| FG001 | Known CNS Malignancy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2019 |
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| Hyperpolarized Carbon C 13 Pyruvate | Drug | Given IV |
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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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Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). |
| Received Interventions |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes. |
| BG001 | Known CNS Malignancy | Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Grade 2 or Higher Toxicities | The measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases) | Posted | Count of Participants | Participants | 2 days (+/-2) after the scan |
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| Other Pre-specified | Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue | The outcome is defined as the number of participants with hyperpolarized carbon C 13 pyruvate magnetic resonance signal detection above background noise level of both lactate and bicarbonate in all tumors screened. | Not Posted | Imaging timepoint (up to 15 minutes to obtain scan) | Participants |
Up to 4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG001 | Known CNS Malignancy | Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). | 0 | 2 | 0 | 2 | 0 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anosmia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Recht, MD | Stanford University | (650) 725-8630 | lrecht@stanford.edu |
| Nov 22, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2021 | Dec 18, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005682 | Gadolinium |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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