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The goal of this clinical trial is to assess the safety and feasibility of the Stratagen Quantitative Prostate MRI Platform when used in addition to the standard scans conducted during the existing prostate MRI sessions.
Participants will:
- Receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratagen Quantitative Prostate MRI Platform | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | Will receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines | All serious adverse events attributable to the Stratagen Quantitative Prostate MRI Platform will be reported. | Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0) |
| • Feasibility: collection of the data necessary to produce measurable quantitative T1 and T2 relaxation times (milliseconds) maps (images) for at least 80% of pixels fully contained within the prostate for at least 80% of subjects | Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Clinic at Sawgrass | Recruiting | Rochester | New York | 14620 | 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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| Virginia Urology | Recruiting | Richmond | Virginia | 23235 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |