FCI Effectiveness in NAFLD Stratification (FIELDS)

NHS Grampian

Status: Suspended

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Device: Field-cycling imaging (FCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05827432

1-100-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

NAFLD

Experimental group

Description:

Participants with different degree of steatohepatitis and NAFLD will undergo one FCI scan.

Treatment:

Device: Field-cycling imaging (FCI)