MRI Calibration Device Tested in Men With Prostate Lesions Before Biopsy
Tests a calibration device with prostate MRI scans in men with lesions awaiting biopsy.
Plain-language title generated from the registry record
Registry title: PRostate Cancer Enhanced Diagnosis by Calibration Technology
Key facts
- Where
- London, United KingdomSee the site
Where in United Kingdom
- University College HospitalLondon, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gold Standard Phantoms
- Trial code
- NCT06607783
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
A Multi-Centre, Pivotal Stage, Study to Determine the Between MRI Scanner Reproducibility of Gold Standard Phantom Calibrated Acquisition Replicator (CARE) for Measurement of Apparent Diffusion Coefficients in the Prostate of Patients With MR Positive Lesions Destined for Biopsy
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 in different scanners using the GSP Phantoms to provide mpMRI images and phantom data for subsequent in silico analysis. The captured images and data will be used to further develop and calibrate the GSP prototype SaMD part of the medical device system, and to establish the degree of optimised reproducibility that can be achieved.
Inclusion: 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.
Exclusion: Previous diagnosis of prostate cancer; Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors; Prostate specific antigen (PSA) level > 20ng/ml within 6 months; Contraindication to MRI scan.