ClinicalTrials.gg
RecruitingNCT05911620HEPACORTUpdated Oct 25, 2023

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

An interventional study of Magnetic resonance elastography (MRE) in Cushing Syndrome and Metabolic Syndrome, sponsored by Central Hospital, Nancy, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Cushing Syndrome
  • Metabolic Syndrome
03

In context

Cushing Syndrome

123 studies on the registry are indexed under Cushing Syndrome; 42 are open to participants now.

This study's planned enrollment of 21 is below the median of 44 across 58 interventional studies indexed under Cushing Syndrome.

Browse Cushing Syndrome studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ;
  • 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

Exclusion Criteria:

  • Person having taken 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 ;
  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (estimated)

Study arms

  • Experimental
    Cushing's Syndrome

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

    Device: Magnetic resonance elastography (MRE)

  • Experimental
    Suspected Cushing's Syndrome

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

    Device: Magnetic resonance elastography (MRE)

  • Active comparator
    Metabolic Syndrome

    Patients with metabolic syndrome

    Device: Magnetic resonance elastography (MRE)

Interventions

  • DeviceMagnetic resonance elastography (MRE)

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

06

What researchers measure

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)

  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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Feb 2026, 28 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2023
First posted
Jun 22, 2023
StartActual
Oct 24, 2023
Primary completionEst.
Feb 28, 2026
CompletionEst.
Aug 31, 2026
Last update
Oct 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05911620
Responsible party
SCHEYER Nicolas (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Jun 22, 2023
Start date
Oct 24, 2023
Primary completion
Feb 28, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Oct 25, 2023

Study contacts

Nicolas SCHEYER, MD
Contact
n.scheyer@chru-nancy.fr
+33383154302
Guillaume DROUOT, PhD
Contact
g.drouot@chru-nancy.fr
+33383157666

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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