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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00065679 | Other Identifier | JHM IRB | |
| 1U01CA183031-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. Preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive but less specific [18F]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFPyL Injection & 18F-NaF | Experimental | A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL injected by slow IV push. A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFPyL Injection | Drug |
| ||
| 18F-NaF |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT | Compare the diagnostic accuracy during visit 2 18F-DCFPyL imaging and visit 3 NaF imaging | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of new or progressive metastatic lesions found on NaF and 18F-DCFPyL | Compare proportion of new or progressive metastatic lesions found on NaF-PET/CT that are DCFPyL- PET/CT (or PET/MRI imaging if available) positive, and vice-versa. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Pomper, MD,PhD | Department of Nuclear Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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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 |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |