A precision and reproducibilty assessment of liver fat measurement by chemical shift magnetic resonance scanning
| ISRCTN | ISRCTN74994614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74994614 |
| Secondary identifying numbers | Study Protocol v2.0 |
- Submission date
- 28/04/2016
- Registration date
- 01/07/2016
- Last edited
- 16/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Department of Hepatopancreatobiliary Surgery
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
| Phone | +44 (0)1254 263555 |
|---|---|
| daren.subar@elht.nhs.uk |
Public
Research and Development Department
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
| Phone | 01254 263555 |
|---|---|
| linda.gregson@elht.nhs.uk |
Study information
| Study design | Single centre. Observational feasibility study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in electronic form. Please study team using public contact details provided. |
| Scientific title | A precision and reproducibility assessment of intra-hepatic fat quantification by chemical shift magnetic resonance |
| Study acronym | LiverPRIMEi |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hepatic steatosis (fatty liver disease) and 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/10/2015 |
| Completion date | 08/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2016 |
| Date of final enrolment | 01/07/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
England
United Kingdom
| Phone | +44(0)1254 263555 |
|---|---|
| linda.gregson@elht.nhs.uk | |
| Website | www.elht.nhs.uk |
"ROR" |
https://ror.org/002pa9318 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 08/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 before publication. |
| IPD sharing plan |
Editorial Notes
16/03/2020: Internal review.
18/10/2017: Internal review.
