MR Image Distortion CorrectionUNDISTORTNCT03151512
UNDISTORT Correction of Distortions in Diffusion MRI V1.0
An observational study of MR Image Distortion Correction and Prostate Cancer, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- MR Image Distortion Correction, Prostate Cancer
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2017to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, NW1 2BU
About this study
Official title: 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.
Read the 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.
- Conditions
- MR Image Distortion Correction, Prostate Cancer
- Keywords
- MRI, distortion correction, Magnetic Resonance Imaging, prostheses
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Dice similarity score to assess distortions
Dice score provides a measure of how similar is the distortion-corrected image to a reference.
Measured: Three Years
Secondary outcomes (2)
Radiological scoring of image quality
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.
Measured: Three Years
Diffusion coefficient consistency
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).
Measured: Three Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start29 Mar 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MR Image Distortion CorrectionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Atkinson, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151512
- Sponsor's protocol ID
- 16/0128
- Acronym
- UNDISTORT
- Status last verified
- Oct 2021
- First submitted
- 3 May 2017
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Distortions in Diffusion MRI
- ClinicalTrials.gov ID
- NCT03151512
- Acronym / sponsor ID
- UNDISTORT / 16/0128
- Conditions
- MR Image Distortion Correction, Prostate Cancer
- Keywords
- MRI, distortion correction, Magnetic Resonance Imaging, prostheses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Radiological scoring of image quality
Time frame: Three Years
Diffusion coefficient consistency
Time frame: Three Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Summary of projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Atkinson principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MR Image Distortion Correction and Prostate Cancer, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dice similarity score to assess distortions (time frame: Three Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.