Stratagen Quantitative Prostate MRI Platform Pilot Study
Interventional
Phase not listed
Urology Clinic at Sawgrass
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.
Treatment Category
Device
Required Mutations
None
Trial Started
2025-09-24
Last Updated by Sponsor
2025-10-21
Estimated Completion
2025-11-30
Eligibility
Inclusion Criteria
* 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
Exclusion Criteria
* 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
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Design Details
AllocationN/A
Intervention ModelSingle Group Assignment
MaskingNone (Open Label)
Number to Enroll45
Arms & Interventions
Arms
Interventions
Type: Experimental
Description:
Interventions:
MRI
Outcome Measures
Primary Outcome Measures
Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelinesBeginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
All serious adverse events attributable to the Stratagen Quantitative Prostate MRI Platform will be reported.
• 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 subjectsBeginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
Secondary Outcome Measures
None
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Trial Sites
This study has 1 trial site
Urology Clinic at Sawgrass Rochester, New York, US