NCT06985238

Stratagen Quantitative Prostate MRI Platform Pilot Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Stratagen Bio, Inc. · Industry
• Sex: Male
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2025-09-24
• Primary completion: 2026-03-31
• Completion: 2026-10-31
• First posted: 2025-05-22
• Last updated: 2026-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study