Actively Recruiting

Phase Not Applicable
Age: 40Years - 90Years
MALE
NCT06985238

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

Age: 40Years - 90Years
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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