PREDICT Study v1.0
Research type
Research Study
Full title
A multicentre, pivotal stage, study to determine the between MRI scanner reproducibility of Gold Standard Phantom (GSP) Calibrated Acquisition Replicator (CARE) for measurement of apparent diffusion coefficients (ADC) in the prostate of patients with MR positive lesions destined for biopsy.
IRAS ID
340447
Contact name
Xavier Golay
Contact email
Sponsor organisation
Gold Standard Phantoms Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
Prostate cancer (Pca) diagnosis currently relies on a blood test (known as the prostate specific antigen, or PSA, test) and a special type of MRI scan, known as a ‘multiparametric’ scan, to help identify whether cancer may be present and decide if a biopsy needed.
The MRI process uses‘diffusion weighted imaging’ (DWI) to provide a map of the prostate, each part is assigned an independent number (known as the apparent diffusion co-efficient, or ADC value). ADCs helps radiologists to identify/confirm the cancer and decide how serious (aggressive) it may be. This helps avoid the need for an invasive biopsy in men who do not have cancer or who have ‘non-significant’ prostate cancer.
Unfortunately, ADC values can vary a lot between different testing sites and MRI scanners and they may not be reliable enough to avoid having to have an invasive biopsy.
The 'GSP CARE Phantom' prototype medical device is a calibration mat that the patient lies on in the MRI scanner. The phantom contains tubes of solutions with known ADC values connected to firbe-optic sensors that are scanned at the same time as the patient. The scan results from the phantom are used to calibrate the image from the MRI to provide a more accurate scan result. This helps healthcare professionals to make a more confident prediction of whether a patient has prostate cancer that will need treatment and to avoid the need for unnecessary biopsies for those that don't.
This study will compare MRI scan results from different test sites to investigate the use of the phantom in different MRI scanners. Patients suspected of having Pca will be scanned on different MRI scanners at different sites and the results will be compared.REC name
London - Stanmore Research Ethics Committee
REC reference
24/LO/0864
Date of REC Opinion
29 Jan 2025
REC opinion
Further Information Favourable Opinion