Recruiting

Stratagen Quantitative MRI

Sponsor:

Stratagen Bio, Inc.

Code:

NCT06985238

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI

Study Details

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

Study ID

NCT06985238

Start date

Sep 24, 2025

Status verified date

May, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Stratagen Quantitative Prostate MRI Platform

Interventions

MRI

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

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) ]
  • • 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 [ Time Frame: Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0) ]

Central Contacts and Locations

Locations

Urology Clinic at Sawgrass

Recruiting

Rochester, New York, United States, 14620

Contacts

Austin Jackson

585-275-0126Austin_Jackson@urmc.rochester.edu

Virginia Urology

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Charles Seabury, MD

804-288-2786Cseabury@uro.com

More Information

Sponsor

Stratagen Bio, Inc.

Last update posted

Mar 6, 2026

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stratagen Bio, Inc. on 2026-03-06.