NCT06607783Recruiting
PRostate Cancer Enhanced Diagnosis by Calibration Technology
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 66 (estimated)
- First submitted
- 18 Sept 2024
- Start date
- 26 Jun 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Gold Standard Phantoms
- Diseases
- Prostate cancer
- NCT number
- NCT06607783
What you commit to
- Study type: Observational
- Planned participants: 66
- From 26 Jun 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of prostate cancer
- Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors
Other
- Prostate specific antigen (PSA) level \> 20ng/ml within 6 months
- Contraindication to MRI scan
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.