Evaluating liver fibrosis in patients with Cushing's syndrome using MRI technology

Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism

This study is testing if MRI technology can help find liver damage in people with Cushing's syndrome to better understand how the condition affects their liver health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central Hospital, Nancy, France (Academic / other)
• Locations: 1 site (Nancy)
• Trial ID: NCT05911620 on ClinicalTrials.gov

What this trial studies

This study aims to explore the severity of liver fibrosis in patients diagnosed with Cushing's syndrome or suspected of having it, utilizing Magnetic Resonance Elastography (MRE) as a diagnostic tool. The hypothesis is that significant liver fibrosis may be present, especially in severe cases of Cushing's syndrome. By assessing liver health in these patients, the study seeks to provide insights into the relationship between Cushing's syndrome and liver fibrosis. This is the first exploratory study of its kind, focusing on this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of Cushing's syndrome, suspected Cushing's syndrome, or metabolic syndrome.

Not a fit: Patients who have taken corticosteroid therapy for more than three months in the past two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods for assessing liver health in patients with Cushing's syndrome, potentially guiding better treatment strategies.

How similar studies have performed: This approach is novel and has not been extensively tested in previous studies, making it a unique exploration in the field.

Eligibility criteria

Inclusion Criteria:

* age ≥ 18 years old;
* Person affiliated to a social security scheme or beneficiary of such a scheme;
* Person having received complete information on the organization of the research and having signed informed consent;
* Person having carried out a preliminary clinical examination adapted to the research.
* Patients with Cushing's syndrome (for the Cushing's Syndrome group)
* Patients with possible Cushing's syndrome (for the suspected Cushing's Syndrome group) defined as response to the dexamethasone supression test with 1 mg of Dexamethasone, with a plasma cortisol assay at 8 am between 18 and 50 µg/L carried out in the 3 months preceding ;
* Patients with metabolic syndrome (for the metabolic syndrome group)

Exclusion Criteria:

* Person having taken corticosteroid therapy for more than 3 months during the 2 years preceding inclusion;
* Person having received corticosteroid therapy of shorter duration with discontinuation less than one month before inclusion;
* Person having taken anticortisolic treatment for more than 3 months during the 2 years preceding inclusion;
* Person with chronic liver disease;
* Person with alcohol misuse, defined by a weekly consumption of more than 10 standard units;
* Person with a morphotype that does not allow an MRI examination to be performed;
* Woman of childbearing age who does not have an effective means of contraception;
* Contraindication to performing an MRI examination.
* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.

Where this trial is running

Nancy

• CHRU Nancy — Nancy, France (Recruiting)

Study contacts

• Study coordinator: Nicolas SCHEYER, MD

Conditions Cushing Syndrome; Metabolic Syndrome