PRostate Cancer Enhanced Diagnosis by Calibration Technology

Condition(s) studied

Investigational drug(s) / intervention(s)

MRI: Standard MRI using phantom.

Study 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.

Eligibility

Primary outcome measure(s)

• Determination of the Reproducibility of GSP CARE Reference Phantom on Different MRI Scanners — From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
  To determine the reproducibility of GSP CARE reference phantom corrected lesion ADC measurements when the phantom is used on different MRI scanners for measurement of ADC in prostate. Voxel-wise median ADC values will be obtained for each lesion region of interest (ROI), referred to in the synopsis as "ADC measurements". The study is designed for 3 pairwise comparisons of 3 MRI scanners, enabling reproducibility determination between each pair of scanners. The study is powered for each pairwise comparison, based on a single lesion per patient.

Trial sites (1)

Other trials for the same condition