Plain English Summary
Background & Aims
The gold standard technique for non-invasive measurement of liver fat has previously been Magnetic Resonance Spectroscopy. This tool is largely confined to the research setting as it requires high energy scanners which are resource intensive. Chemical Shift Magnetic Resonance (CS-MR) poses an alternative which is more applicable in the clinical setting as it can be used on conventional clinical Magnetic Resonance scanners. The accuracy with which CS-MR can repeatedly measure liver fat levels has not previously been assessed. This study aims to assess liver fat levels by using CS-MR in 10 patients on two occasions separated by a minimum of 24 hours. In this time, actual liver fat levels will not have changed. Statistical analysis will then be performed to determine the variation in results CS-MR produces between scans in the same patients. This will provide information on whether CS-MR can be used in studies and clinical practice to accurately detect changes in liver fat levels.
Who can participate?
Anybody over the age of 18 years old with a body mass index greater than 25.
What does the study involve?
Each participant is asked to attend Royal Blackburn Hospital on 2 occasions. During the first visit they are asked to provide a blood sample to assess liver function, circulating blood fat levels and sugar level control. The participants also have a short chemical shift magnetic resonance scan. On the second visit 4 weeks later another chemical shift magnetic resonance scan is performed.
What are the possible benefits?
There are no perceived benefits to participants. Travel expenses will be reimbursed.
When is the study starting?
October 2015 to August 2017
Who is funding the study?
Rosemere Cancer Foundation (UK)
Where is the study running?
East Lancashire Hospitals NHS Trust, Blackburn (UK)
Who is the main contact?
1. Mr Daren Subar (scientific)
daren.subar@elht.nhs.uk
2. Ms Linda Gregson (public)
linda.gregson@elht.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Daren Subar
ORCID ID
Contact details
Department of Hepatopancreatobiliary Surgery
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
01254 263555
daren.subar@elht.nhs.uk
Type
Public
Additional contact
Ms Linda Gregson
ORCID ID
Contact details
Research and Development Department
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
01254 263555
linda.gregson@elht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Study Protocol v2.0
Study information
Scientific title
A precision and reproducibility assessment of intra-hepatic fat quantification by chemical shift magnetic resonance
Acronym
LiverPRIMEi
Study hypothesis
The aim of the study is to determine if chemical shift magentic resonance provides a precise and reproducible method of quantifiying intra-hepatic fat fraction using a clinical magentic resonace scanner.
Null Hypothesis:
1. There is no agreement between repeated quantifications of intra-hepatic fat fraction as measured by chemical shift magnetic resonance
Ethics approval
Not provided at time of registration
Study design
Single centre. Observational feasibility study.
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in electronic form. Please study team using public contact details provided.
Condition
1. Hepatic steatosis or intra-hepatic fat
2. Non alcoholic fatty liver disease
Intervention
10 participants will undergo 2 chemical shift magnetic resonance scans using the clinical magnetic resonance scanner at Royal Blackburn Hospital.
These scans will be performed at least one day apart.
On visit 1, participants will also be asked to provide a blood sample for assessment of liver function, glycaemic control and lipid profile. Weight, height and hip-to-waist ratio will also be recorded. From this body mass index will be calculated.
No further blood samples will be acquired on the second visit.
Intra-person results will be statistically analysed for agreement using the Bland Altmann method with a priori variance levels of 0.2 deemed acceptable.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Intrahepatic fat fraction as measured by 2 Chemical Shift Magnetic Resonance scans greater than 24 hours apart.
Secondary outcome measures
1. Indocyanine Green Plasma Disappearance Rate and Retention at 15 minutes, measured using a PULSiON Indocyanine Green Clearance Testing Device. This will be measured at visit 1 and 4 weeks later
2. BMI, Height, Weight and Hip to Waist ratio, measured at visit 1 and 2
3. Assessment of Liver function, Glycaemic control and Lipid profile, including Bilirubin, AST, ALT, ALP GGT, HbA1c, Random Glucose, Triglycerides and Cholesterol at visit 1.
Overall trial start date
01/10/2015
Overall trial end date
08/08/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Participants must be able to receive and understand verbal and written information regarding the study and give written, informed consent.
2. Participants should have features associated with intra-hepatic fat such as elevated BMI.
3. >18 years old
4. Male or female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Persons under 18 years of age
2. Conditions in which the supine position and breath holds required for MR scanning are not possible
3. Persons who might not adequately understand verbal explanations or written information given in English, or who have special communication needs
4. Persons with contraindications to MR imaging- presence of cardiac pacemaker/artificial heart valve/aneurysm clips/metallic fragments in eyes/cochlear implants
5. Pre-existing chronic liver pathology such as haemachromatosis, viral hepatitis or primary hepatic malignancy
Recruitment start date
01/06/2016
Recruitment end date
01/07/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
East Lancashire Hospitals NHS Trust
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Sponsor information
Organisation
East Lancashire Hospitals NHS Trust
Sponsor details
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
01254 263555
linda.gregson@elht.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Rosemere Cancer Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We anticipate the results of this study to be published by peer-‐reviewed journals and presented at international surgical, anaesthetic and perioperative medicine conferences.
All patient identifiable data will be anonymised befre publication.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary