Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-18 @ 2:18 AM
Study NCT ID:
NCT03754192
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2018-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003570', 'term': 'Cytidine Triphosphate'}], 'ancestors': [{'id': 'D003597', 'term': 'Cytosine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Dual-energy computed tomography and perfusion computed tomography'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pefusion parameters', 'timeFrame': '5 minutes', 'description': 'correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma'}], 'secondaryOutcomes': [{'measure': 'Pathological examination', 'timeFrame': '1 month', 'description': 'Compare data obtained in perfusion computer tomography to the imaging data and to the Histological differentiation grades'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perfusion computer tomography', 'dual-energy computer tomography'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '35419748', 'type': 'DERIVED', 'citation': 'Lewin M, Laurent-Bellue A, Desterke C, Radu A, Feghali JA, Farah J, Agostini H, Nault JC, Vibert E, Guettier C. Evaluation of perfusion CT and dual-energy CT for predicting microvascular invasion of hepatocellular carcinoma. Abdom Radiol (NY). 2022 Jun;47(6):2115-2127. doi: 10.1007/s00261-022-03511-7. Epub 2022 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of Hepatocellular carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the pathological data of the surgical specimens.', 'detailedDescription': 'Dual-energy computer tomography and perfusion computer tomography (General Electric revolution Hight definition Gemstone™ Spectral Imaging) will be performed in all patients. Iodine concentration and quantitative perfusion parameters of the Hepatocellular carcinoma and surrounding liver parenchyma data will be compared with the pathological results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of Hepatocellular carcinoma made according to the guidelines of the American Association for the study of the Liver\n* Affiliation to a national health insurance\n* An indication for hepatic resection during the decision-making stage\n* A request for a pre-operative Computer Tomography in our radiology unit\n* An affiliation to a social security\n* Informed consent given by the patient\n\nExclusion Criteria:\n\n* Previous treatments of Hepatocellular carcinoma (medicated or surgical)\n* Patient under tutorship or curatorship\n* Pregnant or lactating woman'}, 'identificationModule': {'nctId': 'NCT03754192', 'acronym': 'PERCAHEC', 'briefTitle': 'Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prediction Value of Perfusion and Dual Energy Computer Tomography for Microvascular Invasion in Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'APHP180011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'perfusion computed tomography', 'description': 'Will be realsed before liver surgery', 'interventionNames': ['Radiation: perfusion Computed Tomography']}], 'interventions': [{'name': 'perfusion Computed Tomography', 'type': 'RADIATION', 'otherNames': ['Computed tomography'], 'description': 'Will be carried before liver surgery', 'armGroupLabels': ['perfusion computed tomography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94800', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'LEWIN MAITE, MD, PhD', 'role': 'CONTACT', 'email': 'maite.lewin@aphp.fr', 'phone': '00 (33) 6 11 15 06 17'}], 'facility': 'CHU Paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'LEWIN MAITE, MD, Phd', 'role': 'CONTACT', 'email': 'maite.lewin@aphp.fr', 'phone': '00 (33) 6 11 15 06 17'}, {'name': 'DA-MOTA-FERREIRA Jean-Manuel, Radiologic', 'role': 'CONTACT', 'email': 'jean-manuel.da-mota-ferreira@aphp.fr', 'phone': '00 (33) 145592474'}], 'overallOfficials': [{'name': 'LEWIN MAITE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}