Cushing SyndromeHEPACORTNCT05911620
Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism
A study testing Magnetic resonance elastography (MRE) in people with Cushing Syndrome and Metabolic Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Syndrome, Metabolic Syndrome
- What is being tested?
- Magnetic resonance elastography (MRE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy
Nicolas SCHEYER, MD, +33383154302, n.scheyer@chru-nancy.fr
Guillaume DROUOT, PhD, +33383157666, g.drouot@chru-nancy.fr
About this study
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).
- Conditions
- Cushing Syndrome, Metabolic Syndrome
- Being tested
- Magnetic resonance elastography (MRE)
- Medical subject headings
- Cushing Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Cushing's Syndrome | Experimental | Patients with proven autonomic cortisol secretion (Cushing's Syndrome) Receives: Device: Magnetic resonance elastography (MRE) |
| Suspected Cushing's Syndrome | Experimental | Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome) Receives: Device: Magnetic resonance elastography (MRE) |
| Metabolic Syndrome | Active comparator | Patients with metabolic syndrome Receives: Device: Magnetic resonance elastography (MRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (day 0)
Secondary outcomes (12)
Evaluation of the presence of hepatic fibrosis by MRE (kPa).
Evaluation of the presence of hepatic fibrosis by ERM : ERM value ≥ 72.5 kPa.
Measured: Baseline (day 0)
Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).
Measured: Baseline (day 0)
Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).
Measured: Baseline (day 0)
Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).
Measured: Baseline (day 0)
Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).
Measured: Baseline (day 0)
Evolution of transaminases (UI/L) between the diagnosis and the last visit.
Measured: 1 year
Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.
Measured: 1 year
Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit
Measured: 1 year
Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.
Measured: 1 year
Evolution of Albumin (g/L) between the diagnosis and the last visit.
Measured: 1 year
Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.
Measured: 1 year
Evolution of ferritin (ng/mL) between the diagnosis and the last visit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start24 Oct 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SCHEYER Nicolas, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911620
- Sponsor's protocol ID
- 2022-A01786-37
- Acronym
- HEPACORT
- Status last verified
- Oct 2023
- First submitted
- 2 May 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism
- ClinicalTrials.gov ID
- NCT05911620
- Acronym / sponsor ID
- HEPACORT / 2022-A01786-37
- Conditions
- Cushing Syndrome, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cushing's Syndrome | Experimental | Device: Magnetic resonance elastography (MRE)Patients with proven autonomic cortisol secretion (Cushing's Syndrome) |
| Suspected Cushing's Syndrome | Experimental | Device: Magnetic resonance elastography (MRE)Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome) |
| Metabolic Syndrome | Active comparator | Device: Magnetic resonance elastography (MRE)Patients with metabolic syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Cushing's Syndrome, Metabolic Syndrome, Suspected Cushing's Syndrome |
Primary outcome
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.
12 secondary outcomes
Evaluation of the presence of hepatic fibrosis by MRE (kPa).
Time frame: Baseline (day 0)
Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).
Time frame: Baseline (day 0)
Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).
Time frame: Baseline (day 0)
Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).
Time frame: Baseline (day 0)
Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).
Time frame: Baseline (day 0)
Evolution of transaminases (UI/L) between the diagnosis and the last visit.
Time frame: 1 year
Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.
Time frame: 1 year
Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit
Time frame: 1 year
Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.
Time frame: 1 year
Evolution of Albumin (g/L) between the diagnosis and the last visit.
Time frame: 1 year
Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.
Time frame: 1 year
Evolution of ferritin (ng/mL) between the diagnosis and the last visit.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance elastography (MRE) in people with Cushing Syndrome and Metabolic Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas SCHEYER, MD (+33383154302, n.scheyer@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the severity of hepatic fibrosis by MRE (kPa). (time frame: Baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.