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NCT Number: NCT02939456

Comparison Of DIR-MRI And 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.

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Key information

Conditions

Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study 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

Acronym: DIRMP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2016
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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