Clinical trial NCT05827432: FCI Effectiveness in NAFLD Stratification
Official title: Field-Cycling Imaging Effectiveness in Non-alcoholic Fatty Liver Disease Stratification
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Non-Alcoholic Fatty Liver Disease
Field-cycling imaging
Lead sponsor: NHS Grampian
Sponsor class: OTHER_GOV
Collaborators: name: University of Aberdeen
First posted: 2023-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this pilot study is exploring whether field-cycling imaging may be able to detect characteristics of liver disease in patients with different degree of non-alcoholic fatty liver disease (NAFLD) that could be important in reflecting disease progression.

Detailed description: Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of diseases extending from simple steatosis to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Currently, there is a pressing unmet clinical need to develop an effective non-invasive method to differentiate between different types of NAFLD and to support the initiation and monitoring of treatments designed to slow or halt progression of the disease.

Field-cycling imaging (FCI) is an innovative imaging technology pioneered at the University of Aberdeen. It has the ability to image human tissues non-invasively over a wide range of magnetic field strengths, directly informing on multi-scale tissue structure from nanometres to micrometres. This is not possible with traditional MRI. The potential of FCI in imaging NAFLD is particularly promising, due to its high sensitivity in quantifying and distinguishing protein content from fat.

The purpose of this pilot study is exploring whether FCI may be able to detect characteristics of liver disease, in patients with different degree of steatohepatitis and NAFLD, that could be important in reflecting progression of steatosis to liver fibrosis and HCC thereby potentially offering new diagnostic information that cannot be readily obtained with currently available imaging techniques.

Eligibility criteria: Inclusion Criteria:

* Participants with a diagnosis of NAFLD
* Participants must be aged 18 and above
* Participants who meet the safety criteria for undergoing an MRI scan
* Participants who are able to fit inside the scanner
* Participants must be able to give fully informed consent
* Participants must be mobile enough to be positioned onto the FCI scanner couch

Exclusion Criteria:

* MRI-incompatible conditions, as detected in the MRI safety screening sheet
* Participants under 18 years old
* Participants who are unable to communicate in English
* Participants who are unable to give fully informed consent
* Women who are pregnant
* Restrictions to mobility that would prevent the correct positioning in the scanner
* Participants who suffer from claustrophobia

Primary outcomes:
measure: Differentiation of NAFLD types, from steatosis to liver fibrosis, assessed by Field-Cycling Imaging (FCI) scan
timeFrame: At baseline
Secondary outcomes:
measure: NAFLD progression assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles of liver tissue
timeFrame: At baseline
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
Study officials:
affiliation: NHS Grampian
name: Ashis Mukhopadhya, Dr
role: PRINCIPAL_INVESTIGATOR
References: