Liver DiseasesNCT02877602
Patient Understanding of LiverMultiScan
An observational study of Liver Diseases, run by Perspectum at 1 site in United Kingdom.
Trial summary
This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- MRI and Transient Elastography
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Dec 2017
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals with experience of liver disease, either as a sufferer or carer.
Who may be able to join
- Individuals with experience of liver disease.
- Individuals over the age of 16.
- Individuals willing to give informed consent for participation in the study.
Who cannot join
- Individuals with any contraindication to magnetic resonance imaging.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
Oxford, Oxfordshire, OX3 9DU
About this study
This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them.
Read the detailed description
This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them. Each individual will receive at least an MRI scan (LiverMultiScan), with many also receiving a FibroScan (Transient Elastography). Patients will then undergo a focused qualitative interview, as well as filling out a questionnaire. The interviews will be thematically analysed and trends identified by significance.
- Conditions
- Liver Diseases
- Being tested
- MRI, Transient Elastography
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called LiverMultiScan
Transient ElastographyDevice
Also called FibroScan
| Study group | Role | What they receive |
|---|---|---|
| Experience of liver disease | This is defined as either those who have had direct experience of liver disease as sufferers, or the carers of those who have had liver disease. Each individual receives an MRI (LiverMultiScan), with many also receiving a FibroScan. Receives: Device: MRI; Device: Transient Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors effecting MRI experience and understanding.
This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback.
Measured: Immediately (within 1 hour) after undergoing the MRI scan, and receiving results feedback.
Secondary outcomes (1)
Comparison of MRI to ultrasound scan in terms of patient experience.
This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback.
Measured: Immediately (within 1 hour) after undergoing an MRI scan, and ultrasound (FibroScan) scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajarshi Banerjee, BM BCh MRCP MSc DPhil, Principal investigator, Perspectum Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877602
- Sponsor's protocol ID
- Patient LMS
- Status last verified
- Jan 2018
- First submitted
- 17 Aug 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McKay A, Pantoja C, Hall R, Matthews S, Spalding P, Banerjee R. Patient understanding and experience of non-invasive imaging diagnostic techniques and the liver patient pathway. J Patient Rep Outcomes. 2021 Sep 10;5(1):89. doi: 10.1186/s41687-021-00363-5.
PubMed 34508298
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Understanding of LiverMultiScan
- ClinicalTrials.gov ID
- NCT02877602
- Acronym / sponsor ID
- Patient LMS
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Aug 2016 (estimated)
- 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 qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them.
Detailed description
This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them. Each individual will receive at least an MRI scan (LiverMultiScan), with many also receiving a FibroScan (Transient Elastography). Patients will then undergo a focused qualitative interview, as well as filling out a questionnaire. The interviews will be thematically analysed and trends identified by significance.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experience of liver disease | – | Device: MRI, Device: Transient ElastographyThis is defined as either those who have had direct experience of liver disease as sufferers, or the carers of those who have had liver disease. Each individual receives an MRI (LiverMultiScan), with many also receiving a FibroScan. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with experience of liver disease, either as a sufferer or carer.
Key inclusion criteria (3 listed)
- Individuals with experience of liver disease.
- Individuals over the age of 16.
- Individuals willing to give informed consent for participation in the study.
Key exclusion criteria (1 listed)
- Individuals with any contraindication to magnetic resonance imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: LiverMultiScan | Device | Experience of liver disease |
| Transient ElastographyAlso: FibroScan | Device | Experience of liver disease |
Primary outcome
Factors effecting MRI experience and understanding.
Time frame: Immediately (within 1 hour) after undergoing the MRI scan, and receiving results feedback.
This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback.
1 secondary outcome
Comparison of MRI to ultrasound scan in terms of patient experience.
Time frame: Immediately (within 1 hour) after undergoing an MRI scan, and ultrasound (FibroScan) scan.
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 12 Jan 2018.
- Derived from this study: PubMed 34508298McKay A, Pantoja C, Hall R, Matthews S, Spalding P, Banerjee R. Patient understanding and experience of non-invasive imaging diagnostic techniques and the liver patient pathway. J Patient Rep Outcomes. 2021 Sep 10;5(1):89. doi: 10.1186/s41687-021-00363-5.
- Individual participant dataSharing planned: No
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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.
Rajarshi Banerjee, BM BCh MRCP MSc DPhil principal investigator
Perspectum Diagnostics
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 Liver Diseases, run by Perspectum 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 3 inclusion and 1 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 12 Jan 2018. 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?
Factors effecting MRI experience and understanding. (time frame: Immediately (within 1 hour) after undergoing the MRI scan, and receiving results feedback.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877602, which also lists 1 linked publication.
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 12 Jan 2018.