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A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic imaging group | Experimental | Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041 |
|
| Whole body dosimetry group | Experimental | Determination of human dosimetry of the investigation drug [68Ga]P15-041 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]P15-041 | Drug | Imaging by Positron Emission Tomography after injection of [68Ga]P15-041 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time course of uptake of [68Ga]P15-041 in bone metastases | kinetics of [68Ga]P15-041 uptake in known or suspected bone metastases in prostate cancer | 60 minutes post injection |
| Time course of whole body distribution of [68Ga]P15-041 | whole body distribution of [68Ga]P15-041 used for human dosimetry determination | 3 hours post injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 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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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |