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

March 12, 2019 updated by: University Hospitals of North Midlands NHS Trust

Comparison Of Double Inversion Recovery Magnetic Resonance Imaging (Dir-Mri) And Dynamic Contrast Enhanced Magnetic Imaging (Dce-Mri) In Detection Of Prostate Cancer: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • University Hospitals of North Midlands NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DIR-MRI
Participants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)
Other: Magnetic Resonance Imaging
Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of biopsy and DIR-MRI and DCE-MRI findings
Time Frame: 3 months
In order to ascertain if addition of DIR-MRI could improve accuracy of cancer diagnosis
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals of North Midlands NHS Trust

Investigators

  • Principal Investigator: Eric Onwuharine, University Hospitals of North Midlands NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

April 12, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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