Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-01-01 @ 12:40 PM
Study NCT ID:
NCT05911620
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of the severity of hepatic fibrosis by MRE (kPa).', 'timeFrame': 'Baseline (day 0)', 'description': 'Estimation of the severity of hepatic fibrosis in kPa by a non-invasive elastography method : magnetic resonance elastography.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the presence of hepatic fibrosis by MRE (kPa).', 'timeFrame': 'Baseline (day 0)', 'description': 'Evaluation of the presence of hepatic fibrosis by ERM : ERM value ≥ 72.5 kPa.'}, {'measure': 'Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Evolution of transaminases (UI/L) between the diagnosis and the last visit.', 'timeFrame': '1 year'}, {'measure': 'Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.', 'timeFrame': '1 year'}, {'measure': 'Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit', 'timeFrame': '1 year'}, {'measure': 'Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.', 'timeFrame': '1 year'}, {'measure': 'Evolution of Albumin (g/L) between the diagnosis and the last visit.', 'timeFrame': '1 year'}, {'measure': 'Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.', 'timeFrame': '1 year'}, {'measure': 'Evolution of ferritin (ng/mL) between the diagnosis and the last visit.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cushing Syndrome', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': "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.\n\nthe 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age ≥ 18 years old;\n* Person affiliated to a social security scheme or beneficiary of such a scheme;\n* Person having received complete information on the organization of the research and having signed informed consent;\n* Person having carried out a preliminary clinical examination adapted to the research.\n* Patients with Cushing's syndrome (for the Cushing's Syndrome group)\n* 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 ;\n* Patients with metabolic syndrome (for the metabolic syndrome group)\n\nExclusion Criteria:\n\n* Person having taken corticosteroid therapy for more than 3 months during the 2 years preceding inclusion;\n* Person having received corticosteroid therapy of shorter duration with discontinuation less than one month before inclusion;\n* Person having taken anticortisolic treatment for more than 3 months during the 2 years preceding inclusion;\n* Person with chronic liver disease;\n* Person with alcohol misuse, defined by a weekly consumption of more than 10 standard units;\n* Person with a morphotype that does not allow an MRI examination to be performed;\n* Woman of childbearing age who does not have an effective means of contraception;\n* Contraindication to performing an MRI examination.\n* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code."}, 'identificationModule': {'nctId': 'NCT05911620', 'acronym': 'HEPACORT', 'briefTitle': 'Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism', 'orgStudyIdInfo': {'id': '2022-A01786-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Cushing's Syndrome", 'description': "Patients with proven autonomic cortisol secretion (Cushing's Syndrome)", 'interventionNames': ['Device: Magnetic resonance elastography (MRE)']}, {'type': 'EXPERIMENTAL', 'label': "Suspected Cushing's Syndrome", 'description': "Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome)", 'interventionNames': ['Device: Magnetic resonance elastography (MRE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metabolic Syndrome', 'description': 'Patients with metabolic syndrome', 'interventionNames': ['Device: Magnetic resonance elastography (MRE)']}], 'interventions': [{'name': 'Magnetic resonance elastography (MRE)', 'type': 'DEVICE', 'description': 'Magnetic Resonance Imaging (MRI) imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues', 'armGroupLabels': ["Cushing's Syndrome", 'Metabolic Syndrome', "Suspected Cushing's Syndrome"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas SCHEYER, MD', 'role': 'CONTACT', 'email': 'n.scheyer@chru-nancy.fr', 'phone': '+33383154302'}, {'name': 'Guillaume DROUOT, PhD', 'role': 'CONTACT', 'email': 'g.drouot@chru-nancy.fr', 'phone': '+33383157666'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Nicolas SCHEYER, MD', 'role': 'CONTACT', 'email': 'n.scheyer@chru-nancy.fr', 'phone': '+33383154302'}, {'name': 'Guillaume DROUOT, PhD', 'role': 'CONTACT', 'email': 'g.drouot@chru-nancy.fr', 'phone': '+33383157666'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'SCHEYER Nicolas', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}