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FCI Effectiveness in NAFLD Stratification (FIELDS)

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Field-cycling imaging (FCI)
Sponsored by
NHS Grampian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non-Alcoholic Fatty Liver Disease focused on measuring Non-Alcoholic Fatty Liver Disease, Field-cycling imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    NAFLD

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 10, 2023
    Last Updated
    April 21, 2023
    Sponsor
    NHS Grampian
    Collaborators
    University of Aberdeen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05827432
    Brief Title
    FCI Effectiveness in NAFLD Stratification
    Acronym
    FIELDS
    Official Title
    Field-Cycling Imaging Effectiveness in Non-alcoholic Fatty Liver Disease Stratification
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NHS Grampian
    Collaborators
    University of Aberdeen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Alcoholic Fatty Liver Disease
    Keywords
    Non-Alcoholic Fatty Liver Disease, Field-cycling imaging

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NAFLD
    Arm Type
    Experimental
    Arm Description
    Participants with different degree of steatohepatitis and NAFLD will undergo one FCI scan.
    Intervention Type
    Device
    Intervention Name(s)
    Field-cycling imaging (FCI)
    Intervention Description
    FCI scan
    Primary Outcome Measure Information:
    Title
    Differentiation of NAFLD types, from steatosis to liver fibrosis, assessed by Field-Cycling Imaging (FCI) scan
    Description
    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.
    Time Frame
    At baseline
    Secondary Outcome Measure Information:
    Title
    NAFLD progression assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles of liver tissue
    Description
    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.
    Time Frame
    At baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Celia G Alvarez Campano, Dr
    Phone
    +441224437828
    Email
    celia.alvarezcampano@abdn.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashis Mukhopadhya, Dr
    Organizational Affiliation
    NHS Grampian
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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