- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05827432
FCI Effectiveness in NAFLD Stratification (FIELDS)
Field-Cycling Imaging Effectiveness in Non-alcoholic Fatty Liver Disease Stratification
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aberdeen, United Kingdom, AB25 2ZN
- Aberdeen Royal Infirmary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NAFLD
Participants with different degree of steatohepatitis and NAFLD will undergo one FCI scan.
|
FCI scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differentiation of NAFLD types, from steatosis to liver fibrosis, assessed by Field-Cycling Imaging (FCI) scan
Time Frame: At baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NAFLD progression assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles of liver tissue
Time Frame: At baseline
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashis Mukhopadhya, Dr, NHS Grampian
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-100-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Alcoholic Fatty Liver Disease
-
Naga P. ChalasaniDSM Nutritional Products, Inc.CompletedNon-Alcoholic Fatty Liver Disease | Non-Alcoholic Steatohepatitis | Non-Alcoholic Fatty LiverUnited States
-
Medical College of WisconsinENDRA Life Sciences, Inc.WithdrawnFatty Liver | NAFLD | Non-Alcoholic Fatty Liver Disease | Non-alcoholic Steatohepatitis | Non-alcoholic Fatty Liver | NASH | Fatty Liver DiseaseUnited States
-
Michael Ohliger, MD PhDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingNAFLD | Non-Alcoholic Fatty Liver Disease | NASH | Non Alcoholic Fatty Liver | Non Alcoholic SteatohepatitisUnited States
-
Hywel Dda Health BoardCompletedNon-Alcoholic Fatty Liver Disease | Non-alcoholic Steatohepatitis | Non Alcoholic Fatty Liver | Steatosis of LiverUnited Kingdom
-
Cairo UniversityRecruitingNon-Alcoholic Fatty Liver DiseaseEgypt
-
Nehal Abou SeadaCompletedNon-Alcoholic Fatty Liver Disease
-
Better TherapeuticsArizona Liver HealthCompletedNon-Alcoholic Fatty Liver Disease | Non-alcoholic Steatohepatitis | Non-alcoholic Fatty LiverUnited States
-
Badr UniversityNot yet recruitingNon-alcoholic Steatohepatitis NASH | Non-alcoholic Fatty Liver Disease NAFLDEgypt
-
Puerta de Hierro University HospitalHospital Universitario Marqués de ValdecillaNot yet recruitingNon-Alcoholic Fatty Liver Disease | Non Alcoholic SteatohepatitisSpain
-
University Hospital, ToulouseNot yet recruiting
Clinical Trials on Field-cycling imaging (FCI)
-
University of AberdeenNHS GrampianWithdrawnBladder Cancer
-
NHS GrampianUniversity of AberdeenWithdrawnInflammatory Bowel Diseases | ProctosigmoiditisUnited Kingdom
-
NHS GrampianUniversity of AberdeenCompleted
-
University of AberdeenNHS GrampianCompleted
-
University of AberdeenNHS GrampianNot yet recruiting
-
University of AberdeenNHS GrampianNot yet recruitingBreast Cancer | Ductal Carcinoma In SituUnited Kingdom
-
University of AberdeenRecruitingMyocardial InfarctionUnited Kingdom
-
University of AberdeenNHS GrampianRecruiting
-
University of AberdeenNHS GrampianRecruitingStroke AcuteUnited Kingdom