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NCT Number: NCT05911620

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: Baseline (day 0)

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

Secondary outcomes

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

    Time frame: Baseline (day 0)

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

  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)

  5. Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).

    Time frame: Baseline (day 0)

  6. Evolution of transaminases (UI/L) between the diagnosis and the last visit.

    Time frame: 1 year

  7. Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.

    Time frame: 1 year

  8. Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit

    Time frame: 1 year

  9. Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.

    Time frame: 1 year

  10. Evolution of Albumin (g/L) between the diagnosis and the last visit.

    Time frame: 1 year

  11. Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.

    Time frame: 1 year

  12. Evolution of ferritin (ng/mL) between the diagnosis and the last visit.

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume DROUOT, PhD

CONTACT

[email protected]

+33383157666

Nicolas SCHEYER, MD

CONTACT

[email protected]

+33383154302

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: HEPACORT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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