Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT06067035
Status:
UNKNOWN
Last Update Posted:
2023-10-04
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hepatic Small Vessel Neoplasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019043', 'term': 'Vascular Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012983', 'term': 'Soft Tissue Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Imaging findings', 'timeFrame': '12 months', 'description': 'Aspect on US Ultrasound Scan (US)'}], 'secondaryOutcomes': [{'measure': 'Pathological examination', 'timeFrame': '12 months', 'description': 'tumors'}, {'measure': 'Biology', 'timeFrame': '12 months', 'description': 'bilirubin and alkaline phosphatase rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular tumors', 'Hepatic imaging', 'Neoplasm'], 'conditions': ['Hepatic Small Vessel Neoplasm']}, 'descriptionModule': {'briefSummary': 'Small-vessel hepatic tumor is a new tumor entity of vascular origin, described in 2016 by Gill et al, in a series of 17 patients. This rare lesion is difficult to diagnose on imaging because it shares a common radiological semiology with several other differential diagnoses ranging from benign hepatic angioma to more aggressive lesions such as angiosarcoma.', 'detailedDescription': 'The aim of our study is to enable the imaging diagnosis of a new entity: small vessel hepatic tumor in order to improve diagnostic management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with small-vessel liver tumours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological evidence of a small vessel hepatic tumor either on biopsy or surgical specimen\n* Cross-sectional imaging before the biopsy or pre-operatively (CT, MRI)\n\nExclusion Criteria:\n\n* Patient under guardianship or curators'}, 'identificationModule': {'nctId': 'NCT06067035', 'acronym': 'IMAHEP', 'briefTitle': 'Hepatic Small Vessel Neoplasm', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Imaging of Small-vessel Liver Tumours', 'orgStudyIdInfo': {'id': 'APHP220863'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Imaging', 'type': 'OTHER', 'otherNames': ['surgical specimen'], 'description': 'Imaging data from patients with small-vessel liver tumours will be compared with histological data.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MAITE LEWIN, MD, PHD', 'role': 'CONTACT', 'email': 'maite.lewin@aphp.fr', 'phone': '0611150617'}, {'name': 'VALERIE VILGRAIN, MD,PHD', 'role': 'CONTACT', 'email': 'valerie.vilgrain@aphp.fr'}], 'overallOfficials': [{'name': 'MAITE LEWIN, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}