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

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).

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Cushing Syndrome
• Intervention / Treatment: Device: Magnetic resonance elastography (MRE)

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas SCHEYER, MD; Phone Number: +33383154302; Email: n.scheyer@chru-nancy.fr
• Study Contact Backup: Name: Guillaume DROUOT, PhD; Phone Number: +33383157666; Email: g.drouot@chru-nancy.fr

Study Locations

• France
  • Nancy, France
    • Recruiting
    • CHRU Nancy
    • Contact: Nicolas SCHEYER, MD; Phone Number: +33383154302; Email: n.scheyer@chru-nancy.fr
    • Contact: Guillaume DROUOT, PhD; Phone Number: +33383157666; Email: g.drouot@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cushing's Syndrome; Patients with proven autonomic cortisol secretion (Cushing's Syndrome)	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
Experimental: Suspected Cushing's Syndrome; Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome)	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
Active Comparator: Metabolic Syndrome; Patients with metabolic syndrome	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the presence of hepatic fibrosis by MRE (kPa).	Evaluation of the presence of hepatic fibrosis by ERM : ERM value ≥ 72.5 kPa.	Baseline (day 0)
Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).		Baseline (day 0)
Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).		Baseline (day 0)
Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).		Baseline (day 0)
Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).		Baseline (day 0)
Evolution of transaminases (UI/L) between the diagnosis and the last visit.		1 year
Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.		1 year
Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit		1 year
Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.		1 year
Evolution of Albumin (g/L) between the diagnosis and the last visit.		1 year
Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.		1 year
Evolution of ferritin (ng/mL) between the diagnosis and the last visit.		1 year

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Insulin Resistance; Hyperinsulinism; Adrenal Gland Diseases; Syndrome; Metabolic Syndrome; Cushing Syndrome; Adrenocortical Hyperfunction
• Other Study ID Numbers: 2022-A01786-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No