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

Metabolic Syndrome Clinical Trial

— HEPACORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911620
• Other study ID #: 2022-A01786-37
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: October 2023
• Source: Central Hospital, Nancy, France
• Contact: Nicolas SCHEYER, MD
• Phone: +33383154302
• Email: n.scheyer[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: August 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Cushing Syndrome
• Metabolic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).		Baseline (day 0)
Secondary	Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).		Baseline (day 0)
Secondary	Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).		Baseline (day 0)
Secondary	Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).		Baseline (day 0)
Secondary	Evolution of transaminases (UI/L) between the diagnosis and the last visit.		1 year
Secondary	Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.		1 year
Secondary	Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit		1 year
Secondary	Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.		1 year
Secondary	Evolution of Albumin (g/L) between the diagnosis and the last visit.		1 year
Secondary	Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.		1 year
Secondary	Evolution of ferritin (ng/mL) between the diagnosis and the last visit.		1 year