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 — DEVICE
    Will 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)

FacilityCityStateZIPSite coordinators
Urology Clinic at SawgrassRochesterNew York14620
Austin Jackson
585-275-0126
Virginia UrologyRichmondVirginia23235
Charles Seabury, MD
804-288-2786

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