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

Not Applicable

Completed

• Conditions: Cancer of the Prostate
• Interventions: Other: Magnetic Resonance Imaging

• Registration Number: NCT02939456
• Lead Sponsor: University Hospitals of North Midlands NHS Trust

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Primary Completion: 2017-04-12
• Study Completion: 2017-04-30
• Status Verified: 2018-05
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DIR-MRI	Magnetic Resonance Imaging	Participants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)

Primary Outcome Measures

Name	Time	Method
Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI	3 months	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

Secondary Outcome Measures

Name	Time	Method
Correlation of biopsy and DIR-MRI and DCE-MRI findings	3 months	In order to ascertain if addition of DIR-MRI could improve accuracy of cancer diagnosis

Trial Locations

Locations (1)

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, Staffordshire, United Kingdom