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

Primary Purpose

Cushing Syndrome, Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic resonance elastography (MRE)
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cushing Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRU NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Cushing's Syndrome

Suspected Cushing's Syndrome

Metabolic Syndrome

Arm Description

Patients with proven autonomic cortisol secretion (Cushing's Syndrome)

Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome)

Patients with metabolic syndrome

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2023
Last Updated
October 24, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT05911620
Brief Title
Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism
Acronym
HEPACORT
Official Title
Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing Syndrome, Metabolic Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cushing's Syndrome
Arm Type
Experimental
Arm Description
Patients with proven autonomic cortisol secretion (Cushing's Syndrome)
Arm Title
Suspected Cushing's Syndrome
Arm Type
Experimental
Arm Description
Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome)
Arm Title
Metabolic Syndrome
Arm Type
Active Comparator
Arm Description
Patients with metabolic syndrome
Intervention Type
Device
Intervention Name(s)
Magnetic resonance elastography (MRE)
Intervention Description
Magnetic Resonance Imaging (MRI) imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues
Primary Outcome Measure Information:
Title
Estimation of the severity of hepatic fibrosis by MRE (kPa).
Description
Estimation of the severity of hepatic fibrosis in kPa by a non-invasive elastography method : magnetic resonance elastography.
Time Frame
Baseline (day 0)
Secondary Outcome Measure Information:
Title
Evaluation of the presence of hepatic fibrosis by MRE (kPa).
Description
Evaluation of the presence of hepatic fibrosis by ERM : ERM value ≥ 72.5 kPa.
Time Frame
Baseline (day 0)
Title
Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).
Time Frame
Baseline (day 0)
Title
Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).
Time Frame
Baseline (day 0)
Title
Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).
Time Frame
Baseline (day 0)
Title
Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).
Time Frame
Baseline (day 0)
Title
Evolution of transaminases (UI/L) between the diagnosis and the last visit.
Time Frame
1 year
Title
Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.
Time Frame
1 year
Title
Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit
Time Frame
1 year
Title
Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.
Time Frame
1 year
Title
Evolution of Albumin (g/L) between the diagnosis and the last visit.
Time Frame
1 year
Title
Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.
Time Frame
1 year
Title
Evolution of ferritin (ng/mL) between the diagnosis and the last visit.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas SCHEYER, MD
Phone
+33383154302
Email
n.scheyer@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume DROUOT, PhD
Phone
+33383157666
Email
g.drouot@chru-nancy.fr
Facility Information:
Facility Name
CHRU Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas SCHEYER, MD
Phone
+33383154302
Email
n.scheyer@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Guillaume DROUOT, PhD
Phone
+33383157666
Email
g.drouot@chru-nancy.fr

12. IPD Sharing Statement

Learn more about this trial

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

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