Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.

To achieve this:

* The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2\*. The other data will be extracted from usual sequences.
* Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
* Usual blood samples will be completed by samples for the serum library

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Explore the Value of New MR Technology in Non-invasive Quantitative Assessment of Systemic Metabolism, Disease Status and Prognosis in Patients With Metabolic-Associated Fatty Liver Disease

NCT07149571

Nonalcoholic Fatty Liver Disease Metabolic-associated Fatty Liver Disease

RECRUITING

Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non Alcoholic Fatty Liver Disease

NCT03245606

Non-Alcoholic Fatty Liver Disease

COMPLETED

Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis

NCT03142698

Hepatic Steatosis MRI Liver Biopsy +1 more

UNKNOWN NA

Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)

NCT01110577

Non-alcoholic Fatty Liver Disease (NAFLD)

COMPLETED

Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

NCT02873507

Fatty Liver Steatosis of Liver

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight Type 2 Diabetes Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients requiring a liver biopsy

2 additional MRI sequences

Intervention Type OTHER

An additional blood sample

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

2 additional MRI sequences

Intervention Type OTHER

An additional blood sample

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who have been informed about the research
* Patients with national health insurance cover
* Patients who are overweight (BMI \> 25) or have type 2 diabetes suggesting a disturbance of hepatic enzymes (ASAT \< 8 times normal values and ALAT \> twice normal values) after a complete hepatopathy assessment
* Obese patients with a hepatic anomaly (steatosis) revealed by imaging or biological assessment (ASAT \< 8 times normal values and ALAT \> twice normal values) who are eligible for bariatric surgery and a preoperative liver MRI examination.

Exclusion Criteria

* Non-corrected coagulation disorder.
* Patients aged over 80 years
* Patients aged less than 18 years
* Patients without legal protection
* Patients with a contra-indication for MRI (Pacemaker, intraocular metallic foreign body, weight\>150kg)
* Patients without national health insurance cover

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No