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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01289 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| BRN0024 | Other Identifier | OnCore | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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Re-evaluate indication with the referring physicians
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.
This clinical trial compares fluorine F-18 fluoro-dihydroxyphenylalanine (18F-fluorodopa or 18F-FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F-FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (FDOPA-PET/CT or PET/MRI) | Experimental | Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-fluoro-dihydroxyphenylalanine | Drug | Administered intravenously (IV) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Suspicious Lesions Identified by 18F FDOPA PET | The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician. | Up to 30 minutes after injection of F18 FDOPA |
| Percent Agreement of 18F FDOPA PET With Pathology | For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated. | Up to 30 minutes post-injection (at time of scan) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Mittra, MD, PhD | Stanford University Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospitals and Clinics | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (FDOPA-PET/CT or PET/MRI) | Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Positron emission tomography (PET) | Procedure | Component of an 18F-FDOPA PET/CT or PET/MRI scan |
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| Computed tomography (CT) | Procedure | Component of an 18F-FDOPA PET/CT |
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| Magnetic resonance imaging | Procedure | Component of an 18F-FDOPA PET/MRI |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (FDOPA-PET/CT or PET/MRI) | Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week. |
| 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 | Number | 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 Suspicious Lesions Identified by 18F FDOPA PET | The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician. | Posted | Number | suspicious lesion(s) | Up to 30 minutes after injection of F18 FDOPA |
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| Primary | Percent Agreement of 18F FDOPA PET With Pathology | For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated. | Posted | Number | percentage of agreement (sensitivity) | Up to 30 minutes post-injection (at time of scan) |
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72 Months
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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 | Diagnostic (FDOPA-PET/CT or PET/MRI) | Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week. | 0 | 1 | 0 | 1 |
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This study was underpowered due to low enrollment
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erik Mittra, MD, PhD | Stanford University | 650-736-2859 | emittra@stanford.edu |
| ID | Term |
|---|---|
| D004806 | Ependymoma |
| D009837 | Oligodendroglioma |
| D001254 | Astrocytoma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| D018302 | Neoplasms, Neuroepithelial |
| D020339 | Optic Nerve Glioma |
| ID | Term |
|---|---|
| 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 |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C043437 | fluorodopa F 18 |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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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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