Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study
DIRMP
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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2017
CompletedMarch 14, 2019
May 1, 2018
11 months
October 18, 2016
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 months
Secondary Outcomes (1)
Correlation of biopsy and DIR-MRI and DCE-MRI findings
3 months
Study Arms (1)
DIR-MRI
OTHERParticipants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)
Interventions
Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)
Eligibility Criteria
You may qualify if:
- Patients referred for prostate MRI for possible prostate cancer
- Safe to undergo an MRI scan
- Able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Onwuharine
University Hospitals of North Midlands NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2016
First Posted
October 20, 2016
Study Start
June 1, 2016
Primary Completion
April 12, 2017
Study Completion
April 30, 2017
Last Updated
March 14, 2019
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share