Condition category
Digestive System
Date applied
28/04/2016
Date assigned
01/07/2016
Last edited
01/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

www.elht.nhs.uk

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

Publication citations

Additional files

Editorial Notes