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NCT Number: NCT06985238

Stratagen Quantitative Prostate MRI Platform Pilot Study

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology Clinic at Sawgrass, Rochester, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

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

Primary outcomes

  1. 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)

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

  2. • 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)

Sponsors and collaborators

Lead sponsor

Stratagen Bio, Inc.

Industry

Registry information

Official study title

A Pilot Study to Determine Safety and Feasibility of the Stratagen Quantitative Prostate MRI Platform as an Adjunct to Standard of Care MRI When Evaluating for Clinically Significant Prostate Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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