Stratagen Quantitative Prostate MRI Platform Pilot Study
Launched by STRATAGEN BIO, INC. · May 20, 2025
Trial Information
Current as of August 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The Stratagen Quantitative Prostate MRI Platform Pilot Study is a clinical trial aimed at evaluating the safety and effectiveness of a new MRI imaging tool for patients with prostate cancer. This study will add up to 15 minutes of extra MRI scanning time to the standard imaging already being done during prostate MRI sessions. Researchers want to find out if this new tool causes any serious problems and if it can provide useful measurements of prostate tissue through MRI.
To participate in this study, men aged 40 to 90 who have a prostate that might need a biopsy and a PSA level of 2.5 or higher may be eligible. However, individuals who have had a recent prostate biopsy, certain medical implants, or specific previous treatments for prostate cancer won't be able to join. If you qualify, you will receive additional MRI scans, and the information gathered could help improve prostate cancer imaging in the future. This study is not yet recruiting participants, so more information will be available as it progresses.
Gender
MALE
Eligibility criteria
- 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
About Stratagen Bio, Inc.
Stratagen Bio, Inc. is a pioneering biotechnology company dedicated to advancing innovative therapeutic solutions through cutting-edge research and development. With a focus on harnessing the power of biological processes, Stratagen Bio aims to address unmet medical needs across various disease areas. The company is committed to maintaining the highest standards of clinical trial integrity and scientific rigor, collaborating with leading experts and institutions to bring transformative treatments from the lab to the clinic. Through its strategic initiatives and dedication to patient-centered care, Stratagen Bio is positioned to make significant contributions to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported