FCI Effectiveness in NAFLD Stratification

NCT05827432 | Withdrawn

• 1 other identifier: 1-100-22
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Non-Alcoholic Fatty Liver Disease; Field-cycling imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NAFLD progression assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles of liver tissue

  At baseline

Study Arms (1)

NAFLD

EXPERIMENTAL

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

Device: Field-cycling imaging (FCI)

Interventions

Field-cycling imaging (FCI) DEVICE

FCI scan

NAFLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Grampian: lead
• University of Aberdeen: collaborator

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Ashis Mukhopadhya, Dr

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 25, 2023
• Study Start: March 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 26, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)