FCI Effectiveness in NAFLD Stratification | NCT05827432

Studies
FCI Effectiveness in NAFLD Stratification

NCT05827432

Sponsor

NHS Grampian

Status

Withdrawn

Last Update Posted

Apr 1, 2026Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Field-cycling imaging (FCI)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding period ended.

Expanded Access Info

Start Date

Mar 2026Estimated

Primary Completion Date

Mar 2026Estimated

Completion Date

Mar 26, 2026Actual

First Submitted Date

Mar 10, 2023

First Submission Date that Met QC Criteria

Apr 21, 2023

First Posted Date

Apr 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Apr 1, 2026Actual

Name	Class
University of Aberdeen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NAFLD	Experimental	Participants with different degree of steatohepatitis and NAFLD will undergo one FCI scan.	Device: Field-cycling imaging (FCI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Field-cycling imaging (FCI)	Device	FCI scan	NAFLD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ashis Mukhopadhya, Dr	NHS Grampian	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aberdeen Royal Infirmary		Aberdeen		AB25 2ZN	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided