Stratagen Quantitative Prostate MRI Platform Pilot Study

NCT06985238 · tracked via the Priya Life Science USA tracker

Sponsor

Stratagen Bio, Inc.

Phase

Not applicable

Started

2025-09-24

Last updated

2026-03-06

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

MRI

MRI: Will receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.

Study summary

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.

Eligibility

Sex

MALE

Min age

40 Years

Max age

90 Years

Healthy volunteers

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

Primary outcome measure(s)

Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines — Beginning 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 subjects — Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)

Trial sites (2)

Facility	City	Region	Status
Urology Clinic at Sawgrass	Rochester	New York	Recruiting
Virginia Urology	Richmond	Virginia	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06985238 on ClinicalTrials.gov ↗ ← All trials in the USA