UNDISTORT Correction of Distortions in Diffusion MRI V1.0 (UNDISTORT)

October 8, 2021 updated by: University College, London

Correction of Distortions in Diffusion MRI

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University College London Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will recruit patients within the UCLH imaging pathway and healthy participants for research Magnetic Resonance imaging. There is no requirement for participants to be imaged more than once for this study. Following the MR scan, no further involvement is required from the participants. This is a single-centre study and all imaging will take place at UCLH. The de-identified data will be processed by members of the study team within UCL.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dice similarity score to assess distortions
Time Frame: Three Years
Dice score provides a measure of how similar is the distortion-corrected image to a reference.
Three Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiological scoring of image quality
Time Frame: 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.
Three Years
Diffusion coefficient consistency
Time Frame: 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).
Three Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College, London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Atkinson, UCLH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16/0128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The funder would like to see the best use made of data. As yet we are undecided on the scope or mechanism for this, but data would only be shared anonymously and under a material transfer agreement. Participants agree at the time of consent to their data being used in further research and teaching.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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