Diagnostic Accuracy of LI-MRI vs mp-MRI in Prostate Cancer (CLIMATE)
Research type
Research Study
Full title
Comparison of diagnostic accuracy of Luminal Index and Multi-parametric MRI for accelerated detection of significant prostate cancer (CLIMATE)
IRAS ID
281621
Contact name
Shonit Punwani
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2020/09/59 , UCL Data Protection Registration Number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Multi-parametric Magnetic Resonance Imaging (mp-MRI) has become the standard of care in the diagnostic work-up of patients with suspected prostate cancer (PCa). Using a 45-50 minute MRI protocol, the technique has high sensitivity (>90%) for detection of clinically significant disease. However, it has several limitations that should be addressed, specifically: a) only about to 1 in 2 men with suspicious lesions at MRI have significant tumour at biopsy (i.e.: there is a need for improved specificity); b) mp-MRI often suffers from image artefacts causing difficulty in scan interpretation (i.e.: there is a need for improved image quality); c) there is growing concern on the safety of contrast agents used for MRI (i.e.: there is a need to reduce contrast usage).
Recently, a new MRI technology named Luminal Index MRI (LI-MRI) has been introduced. LI-MRI can be easily set-up on any existing clinical MRI scanner and could replace the standard 45-50 minute mp-MRI with single 5-10 minute scan. Preliminary studies showed that, compared to mp-MRI, LI-MRI matches sensitivity, improves specificity, is significantly less prone to image artifacts and does not require the use of contrast agents.
CLIMATE will be a prospective, multi-centre, non-randomised comparative study of mp-MRI and LI-MRI recruiting men with clinical suspicion of prostate cancer that should undergo mp-MRI as part of their standard clinical care. All participants will undergo both mp-MRI and LI-MRI with targeted biopsies performed when suspicious lesion are detected.
The primary aim will be to compare the diagnostic accuracy of LI-MRI and mp-MRI for the detection of significant cancer. Secondary aims will be to compare the proportions of men over diagnosed with non-harmful tumours based on mp-MRI and LI-MRI, to determine the reproducibility between radiologists in scoring LI-MRI and to correlate LI-MRI quantitative metrics with tumour aggressiveness.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0057
Date of REC Opinion
27 Jul 2021
REC opinion
Further Information Favourable Opinion