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NCT05020522: CLIMATE

Comparison of Diagnostic Accuracy of Luminal Index and MP MRI for Accelerated deTEction of Significant Prostate Cancer

Status unknown NA Last updated 3 October 2023
What this trial tests

NA trial testing Luminal Index MRI (LI-MRI) in Prostate Cancer in 702 participants. Status unknown.

Timeline
1 May 2022
Primary endpoint
1 March 2024
1 March 2025

Quick facts

Lead sponsorUniversity College, London
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment702
Start date1 May 2022
Primary completion1 March 2024
Estimated completion1 March 2025
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University College, London

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multi-parametric (mp) MRI has now internationally been incorporated as standard of care in the work-up of participants with suspected prostate cancer. The standard mpMRI protocol requires 30-45 minutes to be performed and has a sensitivity and specificity of approximately 90% and 50% for the detection of clinically significant prostate cancer. Compared to the non-targeted systematic transrectal ultrasound (TRUS) biopsy approach in men with clinically suspected prostate cancer (e.g.: elevated PSA), performing mpMRI as a triage test allows to detect clinically significant cancer in more men (38% vs 26%) and clinically insignificant cancer in less men (9% vs 22%), while avoiding biopsy in roughly one third of men. However, there is need for improvement in the prostate diagnostic pathway even after incorporation of mp-MRI, specifically mpMRI can miss significant cancer in around 10% of cases and only 50% of positive scans turn out to harbor significant cancer at biopsy. Moreover, the key functional imaging sequence of mp-MRI (i.e.: DWI) often suffers from image artifacts causing difficulty in scan interpretation. To address these issues the investigators aim to investigate Luminal Index MRI (LI-MRI), a novel method of MR imaging that requires only up to 10 minutes to be performed and doesn't require the use of contrast media. LI-MRI has shown promising results for the characterization of prostate cancer. In this study the diagnostic performance of LI-MRI and mpMRI for the detection of prostate cancer will be directly compared.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The 'Comparison of diagnostic accuracy of Luminal Index and standard of care MRI for Accelerated deTEction of prostate cancer' (CLIMATE) trial protocol.
    Al-Hammouri T, Brembilla G, Brizmohun M, Tuazon J, et al · · 2026 · PMID 41582606 · DOI 10.1111/bju.70108

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Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other University College, London trials

Trials by the same sponsor.

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Data sources for this page

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