FCI Effectiveness in NAFLD Stratification

NCT ID: NCT05827432

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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NAFLD

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

Group Type EXPERIMENTAL

Field-cycling imaging (FCI)

Intervention Type DEVICE

FCI scan

Interventions

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Field-cycling imaging (FCI)

FCI scan

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aberdeen

OTHER

Sponsor Role collaborator

NHS Grampian

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashis Mukhopadhya, Dr

Role: PRINCIPAL_INVESTIGATOR

NHS Grampian

Locations

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Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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1-100-22

Identifier Type: -

Identifier Source: org_study_id

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