FCI Effectiveness in NAFLD Stratification

Non-Alcoholic Fatty Liver Disease Clinical Trial

— FIELDS  

Official title:

Field-Cycling Imaging Effectiveness in Non-alcoholic Fatty Liver Disease Stratification

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05827432
• Other study ID #: 1-100-22
• Status: Suspended
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: NHS Grampian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Device:
• Field-cycling imaging (FCI)
FCI scan

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen

Sponsors (2)

Lead Sponsor	Collaborator
NHS Grampian	University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differentiation of NAFLD types, from steatosis to liver fibrosis, assessed by Field-Cycling Imaging (FCI) scan	Validation of FCI T1 dispersion profiles as a non-invasive technology to map out structural information on NAFLD that is not available by standard methods, by distinguishing protein content from fat, with application for medical research.	At baseline
Secondary	NAFLD progression assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles of liver tissue	Exploring the effectiveness of FCI T1 dispersion profiles of liver protein content, fat content, and fibrotic tissue in participants with NAFLD as a method for non-invasive assessment of disease progression.	At baseline