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

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2026-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Cushing Syndrome Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cushing's Syndrome

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

Group Type EXPERIMENTAL

Magnetic resonance elastography (MRE)

Intervention Type DEVICE

Magnetic Resonance Imaging (MRI) imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues

Suspected Cushing's Syndrome

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

Group Type EXPERIMENTAL

Magnetic resonance elastography (MRE)

Intervention Type DEVICE

Magnetic Resonance Imaging (MRI) imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues

Metabolic Syndrome

Patients with metabolic syndrome

Group Type ACTIVE_COMPARATOR

Magnetic resonance elastography (MRE)

Intervention Type DEVICE

Magnetic Resonance Imaging (MRI) imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues

Interventions

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Magnetic resonance elastography (MRE)

Magnetic Resonance Imaging (MRI) imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No