- PRostate Cancer Enhanced Diagnosis by Calibration Technology — Recruiting • Oncology • NCT06607783.
- Sponsor: Gold Standard Phantoms.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
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The CARE® Phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient (ADC) in the prostate of patients undergoing a multi-parametric MRI (mpMRI) scan to detect prostate cancer. The final device system will comprise three elements: a calibration mat containing phantoms and embedded monitoring software, a docking station to transfer data from the phantoms, and software as a medical device (SaMD) for calibrating the resulting mpMRI images. In this clinical trial, patients will undergo MRI scanning…
- : * Men aged 18 years and older undergoing investigations for PCa. * Standard of Care MRI conducted. * One or more lesions with a Likert score of 3 or above identified on clinical reports. * Planned targeted biopsy within 6 months from the date of clinical care MRI. * Willing and able to provide written informed consent.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.