Actively Recruiting
Stratagen Quantitative Prostate MRI Platform Pilot Study
Led by Stratagen Bio, Inc. · Updated on 2026-03-06
75
Participants Needed
2
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stratagen Quantitative Prostate MRI Platform Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has a prostate that would be considered for biopsy
- Age 40 to 90 years
- PSA 6 2.5
- Subject has been informed of the nature of the study and has provided written informed consent
You will not qualify if you...
- Contraindication for MRI
- Prostate biopsy within the previous 12 weeks
- Implant in the pelvis that may cause artifact on MRI (e.g. hip replacement)
- History of prostatectomy or other local prostate cancer therapy (e.g., cryotherapy or brachytherapy), or previous pelvic irradiation
- Currently enrolled in another investigational drug or device study that clinically interferes with this study
- Unable to comply with the study requirements or follow up schedule
- Any condition the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Urology Clinic at Sawgrass
Rochester, New York, United States, 14620
Actively Recruiting
2
Virginia Urology
Richmond, Virginia, United States, 23235
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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