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A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:
The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways:
The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-PSMA-1007 | Experimental | 18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-PSMA-1007 | Drug | 18F-PSMA-1007 intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - immediate | The participant will be screened for adverse effects immediately post-injection | Immediately after tracer injection |
| Safety - post scan | The participant will be screened for adverse effects immediately after the scan (approx 2.5 hours after injection). | 2.5 hours after tracer injection |
| Safety - delayed | The participant will be provided information to contact the study team to self-report and delayed adverse events (1-7 days post-injection) | 1-7 days after tracer injection |
| Non-specific bone lesion assessment (NSBLs) | SUVmax and anatomic location of NSBLs (max 5 per participant) will be compared to a reference standard 1 year after tracer injection | 1 year after tracer injection |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan T Abele, MD | Contact | 780-407-6907 | jabele@ualberta.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Recruiting | Edmonton | Alberta | T6G 2R3 | Canada |
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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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Two-centre prospective cohort phase III study
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |