Stratagen Quantitative Prostate MRI Platform Pilot Study

NCT06985238 | Recruiting FDA Device

• 1 other identifier: ST-25-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines

  All serious adverse events attributable to the Stratagen Quantitative Prostate MRI Platform will be reported.

  Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)

• • 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)

Study Arms (1)

Stratagen Quantitative Prostate MRI Platform

EXPERIMENTAL

Device: MRI

Interventions

MRI DEVICE

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

Stratagen Quantitative Prostate MRI Platform

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stratagen Bio, Inc.: lead

Study Sites (2)

Urology Clinic at Sawgrass

Rochester, New York, 14620, United States

RECRUITING

Virginia Urology

Richmond, Virginia, 23235, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 22, 2025
• Study Start: September 24, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-05

Locations

US (2)