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

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ClinicalTrials.gov Identifier: NCT02939456
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cancer of the Prostate Other: Magnetic Resonance Imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : June 2016
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939456


Locations
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United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Sponsors and Collaborators
University Hospitals of North Midlands NHS Trust
Investigators
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Principal Investigator: Eric Onwuharine University Hospitals of North Midlands NHS Trust

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Responsible Party: University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier: NCT02939456     History of Changes
Other Study ID Numbers: 1139
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospitals of North Midlands NHS Trust:
prostate
cancer
MRI

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases