Stratagen Quantitative Prostate MRI Platform Pilot Study

Stratagen Bio, Inc.

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Device: MRI

Study type

Interventional

Funder types

Industry

Identifiers

NCT06985238

ST-25-001

Details and patient eligibility

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.

Enrollment

45 estimated patients

Sex

Male

Ages

40 to 90 years old

Volunteers

No 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