Stratagen Quantitative Prostate MRI Platform Pilot Study
Part of paid clinical trials in Rochester, New York.
- Sponsor
- Stratagen Bio, Inc.
- Study ID
- NCT06985238
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 40 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- MRI — DEVICEWill receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.
Study Details
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. * What severe problems, if any, occur because of the use of the Stratagen Quantitative Prostate MRI Platform? * Can the data collected be used to measure quantitative MRI parameters? Participants will: \- Receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.
Key Dates
- Start date
- Sep 24, 2025
- Status verified
- May 2025
- Primary completion
- Mar 31, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 75 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DEVICE_FEASIBILITY
Arms
- Experimental: Stratagen Quantitative Prostate MRI Platform
Primary Outcome Measure
Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines [ Time Frame: Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0) ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Urology Clinic at Sawgrass | Rochester | New York | 14620 | |
| Virginia Urology | Richmond | Virginia | 23235 |
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