Prostate Cancer
Conditions
Brief 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.
Interventions
DEVICEMRI
Will receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.
Sponsors
Stratagen Bio, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines | Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0) | All serious adverse events attributable to the Stratagen Quantitative Prostate MRI Platform will be reported. |
| • 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 | Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0) | — |
Countries
United States
Outcome results
None listed