Back to resultsComparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study (DIRMP)
Primary Purpose
Cancer of the Prostate
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer of the Prostate focused on measuring prostate, cancer, MRI
Eligibility Criteria
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
Sites / Locations
- University Hospitals of North Midlands NHS Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DIR-MRI
Arm Description
Participants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02939456
First Posted
October 18, 2016
Last Updated
March 12, 2019
Sponsor
University Hospitals of North Midlands NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02939456
Brief Title
Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study
Acronym
DIRMP
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 12, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals of North Midlands NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Prostate
Keywords
prostate, cancer, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DIR-MRI
Arm Type
Other
Arm Description
Participants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)
Primary Outcome Measure Information:
Title
Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI
Description
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 Outcome Measure Information:
Title
Correlation of biopsy and DIR-MRI and DCE-MRI findings
Description
In order to ascertain if addition of DIR-MRI could improve accuracy of cancer diagnosis
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Onwuharine
Organizational Affiliation
University Hospitals of North Midlands NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of North Midlands NHS Trust
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study
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