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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01067 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PROS0068 | Other Identifier | OnCore | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.
PRIMARY OBJECTIVES:
Evaluate the feasibility and biodistribution of 68Ga-PSMA.
OUTLINE:
Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later.
After completion of study, patients are followed up at 24 hours and 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (68Ga-PSMA PET/CT or PET/MRI) | Experimental | Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Part of PET/CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution | The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI. | an estimated average of 1 hour |
| Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution | The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI. | an estimated average of 1 hour |
| Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio) | Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background. | an estimated average of 1 hour |
| Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio) | Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan | Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed. | an estimated average of 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Iagaru | Stanford Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23179945 | Background | Afshar-Oromieh A, Malcher A, Eder M, Eisenhut M, Linhart HG, Hadaschik BA, Holland-Letz T, Giesel FL, Kratochwil C, Haufe S, Haberkorn U, Zechmann CM. PET imaging with a [68Ga]gallium-labelled PSMA ligand for the diagnosis of prostate cancer: biodistribution in humans and first evaluation of tumour lesions. Eur J Nucl Med Mol Imaging. 2013 Apr;40(4):486-95. doi: 10.1007/s00259-012-2298-2. Epub 2012 Nov 24. | |
| 26659347 | Result | Minamimoto R, Hancock S, Schneider B, Chin FT, Jamali M, Loening A, Vasanawala S, Gambhir SS, Iagaru A. Pilot Comparison of (6)(8)Ga-RM2 PET and (6)(8)Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2016 Apr;57(4):557-62. doi: 10.2967/jnumed.115.168393. Epub 2015 Dec 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (68Ga-PSMA PET/CT or PET/MRI) | Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later. Computed Tomography: Undergo PET/CT Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo PET/MRI Positron Emission Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/MRI |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (68Ga-PSMA PET/CT or PET/MRI) | Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution | The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI. | 45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background. | Posted | Mean | Standard Deviation | SUVmax | an estimated average of 1 hour |
|
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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 (68Ga-PSMA PET/CT or PET/MRI) | Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later. |
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lack of correlation with pathology results for all patients; limited patient enrollment (pilot study)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrei Iagaru, MD | Stanford University | 650-725-4711 | aiagaru@stanford.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) | Drug | Intravenously-administered (IV) radioisotope |
|
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| Magnetic Resonance Imaging | Procedure | Part of PET/MRI scan |
|
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| Positron Emission Tomography | Procedure | Part of PET/CT and/or PET/MRI scans |
|
|
| an estimated average of 1 hour |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
|
|
| Primary | Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution | The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI. | 45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background. | Posted | Mean | Standard Deviation | SUVmean | an estimated average of 1 hour |
|
|
|
| Primary | Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio) | Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background. | 45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background. | Posted | Mean | Standard Deviation | F/N ratio | an estimated average of 1 hour |
|
|
|
| Primary | Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio) | Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background. | 45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background. | Posted | Mean | Standard Deviation | F/N ratio | an estimated average of 1 hour |
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| Secondary | Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan | Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed. | The population analyzed included all participants receiving Ga-68 PSMA PET/CT or PET/MRI scan. | Posted | Number | participants | an estimated average of 2 hours |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |