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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnetic resonance elastography (MRE)

    Device

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

Treatment groups

21 Participants
are divided into 3 treatment groups
Group A: Cushing's SyndromeExperimental treatment 1 intervention
Group B: Suspected Cushing's SyndromeExperimental treatment 1 intervention
Group C: Metabolic SyndromeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Estimation of the severity of hepatic fibrosis by MRE (kPa).

Estimation of the severity of hepatic fibrosis in kPa by a non-invasive elastography method : magnetic resonance elastography.

Time frame
Baseline (day 0)

Secondary outcomes

1

Evaluation of the presence of hepatic fibrosis by MRE (kPa).

Evaluation of the presence of hepatic fibrosis by ERM : ERM value ≥ 72.5 kPa.

Time frame
Baseline (day 0)
2

Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).

Time frame
Baseline (day 0)
3

Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).

Time frame
Baseline (day 0)
4

Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).

Time frame
Baseline (day 0)

Other outcomes

Sponsors and contacts

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