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UNDISTORT Correction of Distortions in Diffusion MRI V1.0

Sponsor
University College, London (Other)
Overall Status
Completed
CT.gov ID
NCT03151512
Collaborator
(none)
37
Enrollment
1
Location
48.1
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and brings together a team from UCL Division of Medicine, Computer Science and University College London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical algorithms to reduce the distortions in MR images, especially of the prostate.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and brings together a team from UCL Division of Medicine, Computer Science and University College London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical algorithms to reduce the distortions in MR images, especially of the prostate. Current NICE guidelines include a type of MR imaging called Diffusion Weighted MRI for the detection of tumour within the prostate, and for active surveillance of low risk confirmed disease. However, approximately 40% of prostate diffusion images suffer from severe localised distortions and this is most marked in the peripheral zone of the prostate where 75% of prostate cancers occur. The source of these distortions is magnetic field imperfections due to the presence of rectal gas or metallic hip implants.

    The research study will ask both healthy volunteers and patients to undergo research MR scans and use the acquired data for analysis. For patients, the scans may be either additional sequences acquired during an extended clinical session, or a separate additional session entirely for research.

    The output from the research will be modified ways to run an MR scanner and compute the final images.

    The work should lead to improved diagnostic accuracy and a reduced number of non-diagnostic studies. It will have broader impact through application to diffusion imaging of other body sites, including whole-body diffusion MRI and non-cancer applications. If successful, the results would provide evidence for a larger trial with the eventual outcome being manufacturers incorporating modified MR sequences and data processing into clinical systems worldwide.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    37 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correction of Distortions in Diffusion MRI
    Actual Study Start Date :
    Mar 29, 2017
    Actual Primary Completion Date :
    Mar 31, 2021
    Actual Study Completion Date :
    Mar 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Dice similarity score to assess distortions [Three Years]

      Dice score provides a measure of how similar is the distortion-corrected image to a reference.

    Secondary Outcome Measures

    1. Radiological scoring of image quality [Three Years]

      Diffusion images will be scored blinded to correction scheme on a scale: 1 - undiagnostic, 2- distorted but diagnostic, 3 - undistorted. The change in score following the proposed method will be reported.

    2. Diffusion coefficient consistency [Three Years]

      Diffusion coefficients (ADC) in relatively undistorted regions will be compared pre and post distortion correction to quantify any changes (if the algorithm is working correctly, none are expected in these regions).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • For the development and testing phases, there are no specific inclusion criteria. Assessment of the primary outcome measure (reduced distortions) also does not require specific inclusion criteria. The intended application of our methods is to prostate cancer and this is reflected in some of the secondary outcome measures. Recruitment will come from the UCLH imaging bookings system. This list will include many men having prostate scans and many of these will subsequently be found to have at least a suspicion of cancer. Note there is no requirement for a suspicion of cancer to be recruited for the study.
    Exclusion Criteria:

    • Subjects unable to have an MRI scan due to contraindications for MRI, for example, pacemaker and certain other implants, severe claustrophobia.

    • Subjects unable to give informed consent.

    • Children and vulnerable populations.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University College London Hospital London United Kingdom NW1 2BU

    Sponsors and Collaborators

    • University College, London

    Investigators

    • Principal Investigator: David Atkinson, UCLH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University College, London
    ClinicalTrials.gov Identifier:
    NCT03151512
    Other Study ID Numbers:
    • 16/0128
    First Posted:
    May 12, 2017
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University College, London
    MRI
    distortion correction
    Magnetic Resonance Imaging
    prostheses
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Oct 15, 2021