Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stratagen Quantitative Prostate MRI Platform
- interventionNames
- Device: MRI
Primary outcomes (2)
- measure
- Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines
- timeFrame
- Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
- description
- All serious adverse events attributable to the Stratagen Quantitative Prostate MRI Platform will be reported.
- measure
- • 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
- timeFrame
- Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
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