A Comparison of the Diagnostic Accuracy of Luminal Index Magnetic Resonance Imaging and Multi-parametric Magnetic Resonance Imaging for the Accelerated Detection of Significant Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Men with clinically suspected prostate cancer and referred for prostate MRI

• Willing and able to provide a written informed consent

Locations
Other Locations
United Kingdom
University College London Hospitals NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Trial Manager
ncita.climate@ucl.ac.uk
02076795279
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 702
Treatments
Other: MRI scan
Mp-MRI, LI-MRI, plasma DNA methylation signature (optional)
Related Therapeutic Areas
Sponsors
Leads: University College, London

This content was sourced from clinicaltrials.gov