Stratagen Quantitative Prostate MRI Platform Pilot Study
Recruiting · NCT06985238 · Interventional (participants receive a specific treatment) · Lead sponsor: Stratagen Bio, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
MRI
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.
Who can take part
Age range
40 Years to 90 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 2 US states.
- Urology Clinic at Sawgrass - Rochester, New York, United States
- Virginia Urology - Richmond, Virginia, United States