NCT02877602

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

August 17, 2016

Last Update Submit

January 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Immediately (within 1 hour) after undergoing an MRI scan, and ultrasound (FibroScan) scan.

Study Arms (1)

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.

Device: MRIDevice: Transient Elastography

Interventions

MRIDEVICE
Also known as: LiverMultiScan
Experience of liver disease
Also known as: FibroScan
Experience of liver disease

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with experience of liver disease, either as a sufferer or carer.

You may qualify if:

  • Individuals with experience of liver disease.
  • Individuals over the age of 16.
  • Individuals willing to give informed consent for participation in the study.

You may not qualify if:

  • Individuals with any contraindication to magnetic resonance imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Rajarshi Banerjee, BM BCh MRCP MSc DPhil

    Perspectum Diagnostics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 24, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations