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

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Cushing Syndrome; Metabolic Syndrome

Treatments: Device: Magnetic resonance elastography (MRE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05911620

2022-A01786-37

Details and patient eligibility

About

The main hypothesis of the HEPACORT study is that upon diagnosis of endogenous Cushing's syndrome, significant liver fibrosis may be present, particularly in the most severe forms of Cushing's syndrome.

the HEPACORT study is the first exploratory study to assess the severity of liver fibrosis in patients with Cushing's syndrome or suspected of presenting by Magnetic Resonance Elastography (MRE).

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Cushing's Syndrome

Experimental group

Description:

Patients with proven autonomic cortisol secretion (Cushing's Syndrome)

Treatment:

Device: Magnetic resonance elastography (MRE)

Suspected Cushing's Syndrome

Experimental group

Description:

Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome)

Treatment:

Device: Magnetic resonance elastography (MRE)

Metabolic Syndrome

Active Comparator group

Description:

Patients with metabolic syndrome

Treatment:

Device: Magnetic resonance elastography (MRE)