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Recruiting NCT05911620

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

No phase Interventional Cushing Syndrome Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic resonance elastography (MRE).
Who it may be relevant to
Registry conditions: Cushing Syndrome, Metabolic Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Device 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

Primary outcome measures

  • Estimation of the severity of hepatic fibrosis by MRE (kPa). [Time frame: Baseline (day 0)]
Secondary outcome measures (12)
  • Evaluation of the presence of hepatic fibrosis by MRE (kPa). [Time frame: Baseline (day 0)]
  • Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa). [Time frame: Baseline (day 0)]
  • Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa). [Time frame: Baseline (day 0)]
  • Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa). [Time frame: Baseline (day 0)]
  • Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa). [Time frame: Baseline (day 0)]
  • Evolution of transaminases (UI/L) between the diagnosis and the last visit. [Time frame: 1 year]
  • Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit. [Time frame: 1 year]
  • Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit [Time frame: 1 year]
  • Evolution of Bilirubin (mg/L) between the diagnosis and the last visit. [Time frame: 1 year]
  • Evolution of Albumin (g/L) between the diagnosis and the last visit. [Time frame: 1 year]
  • Evolution of platelets (platelets/mm3) between the diagnosis and the last visit. [Time frame: 1 year]
  • Evolution of ferritin (ng/mL) between the diagnosis and the last visit. [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHRU Nancy — Nancy

Identifiers

NCT: NCT05911620 · 2022-A01786-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗