Stratagen Quantitative Prostate MRI Platform Pilot Study
Recruiting now · Not applicable
Conditions studied: Prostate Cancer
In brief
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 facts
- Study ID
- NCT06985238
- Run by
- Stratagen Bio, Inc.
- People needed
- 75
- Starts
- 2025-09-24
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2026-03-06
Who can join
Age: 40 and older, up to 90. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Subject has a prostate that would be considered for biopsy
- Age 40-90 years
- PSA ≥ 2.5
- Subject has been informed of the nature of the study and has provided written informed consent
You may not qualify if…
- 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
Where it is running
- Urology Clinic at Sawgrass — Rochester, New York, United States (enrolling)
- Virginia Urology — Richmond, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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