NCT02939456 - Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study | Crick

Overview

This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team.

This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team. The research team will look at the variability of LNR score amongst the two scan typed and the DCE-MRI and DIR-MRI images will be correlated with biopsy results to give an indication of the accuracy.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Cancer of the Prostate

Interventions

Magnetic Resonance ImagingOTHER

Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients referred for prostate MRI for possible prostate cancer * Safe to undergo an MRI scan * Able to give informed consent Exclusion Criteria: * MRI referrals where prostate cancer is not the question * Patients who are not safe to undergo an MRI scan * Patients who have undergone prostate biopsy in the previous 10 weeks * Patients unable to give informed consent

Locations (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom

Outcomes

Primary Outcomes

Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI

In order to inform a sample size calculation for a subsequent, fully powered equivalence trial Is DIR-MRI equivalent to DCE-MRI in detection of prostate cancer

Time frame: 3 months

Secondary Outcomes

Correlation of biopsy and DIR-MRI and DCE-MRI findings

In order to ascertain if addition of DIR-MRI could improve accuracy of cancer diagnosis

Time frame: 3 months