NCT06607783

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 66 (estimated)
• Sponsor: Gold Standard Phantoms · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancers

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI	Standard MRI using phantom.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2024-09-23
• Last updated: 2025-08-28

Locations

1 site across 1 country: United Kingdom