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CompletedNCT02939456DIRMPUpdated Mar 14, 2019

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

An interventional study of Magnetic Resonance Imaging in Cancer of the Prostate, sponsored by University Hospitals of North Midlands NHS Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by University Hospitals of North Midlands NHS Trust · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • Cancer of the Prostate

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Keywords

  • prostate
  • cancer
  • MRI
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 150 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University Hospitals of North Midlands NHS Trust is the lead sponsor of 28 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients referred for prostate MRI for possible prostate cancer
  • Safe to undergo an MRI scan
  • Able to give informed consent

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • 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

Interventions

  • OtherMagnetic Resonance Imaging

    Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)

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What researchers measure

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

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

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Study locations

1 site
  • University Hospitals of North Midlands NHS Trust
    Stoke-on-Trent, Staffordshire ST4 6QG, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02939456
Lead sponsor
University Hospitals of North Midlands NHS Trust
Responsible party
Sponsor
First posted
Oct 20, 2016
Start date
Jun 2016
Primary completion
Apr 12, 2017
Completion
Apr 30, 2017
Last update
Mar 14, 2019

Study contacts

Eric Onwuharine
principal investigator · University Hospitals of North Midlands NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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