Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 2:06 PM
Study NCT ID:
NCT05772403
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast Enhanced Ultrasound (CEUS) in Atypical Liver Nodules in Patients With Chronic Liver Disease
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The role of CEUS in evaluating atypic liver lesions on contrast-enhanced CT or MRI.', 'timeFrame': 'Between January 2018 and January 2023', 'description': 'The primary endpoint is to assess the contrastographic behaviour of nodules suspected of HCC and defined as atypical by contrast-enhanced CT and MRI, using CEUS. Prevalence of CEUS LI-RADS categories among atypical nodules will be described.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The present study aims to investigate the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS classification.', 'detailedDescription': 'This retrospective study investigates the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. All CEUS exams were performed, recorded, and analyzed by two experienced operators (\\>10 years of experience with abdominal US and CEUS). Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS (LR) classification. If the analyzed nodule shows a typical hallmark on CEUS (LR-5), that is arterial phase hyperenhancement with late-onset (\\>60 s) washout of mild intensity, it is definitively considered HCC and have been treated appropriately. Categories LR-3 and LR-4 comprise nodules with different combinations of arterial and venous phase enhancement features, expected to correspond to an intermediate or high probability of lesions to be HCC. Patients with LR-3 or LR-4 nodules underwent follow-up; in some cases they underwent biopsy.\n\nLR-M is used to classify high-probability malignant lesions but nonspecific for HCC; these nodules underwent biopsy for further characterization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed for liver cirrhosis or chronic liver disease with increased risk of HCC (HBV-related hepatopathy or fibrosis F3) and diagnosed with liver atypical nodules on contrast-enhanced CT or MRI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of liver cirrhosis or chronic liver disease with increased risk of HCC\n* diagnosis of atypical nodules on contrast-enhanced CT or MRI\n\nExclusion Criteria:\n\n* less than 18 years of age\n* pregnancy\n* typical nodules on contrast-enhanced CT or MRI\n* non-visualized nodule on B-mode US\n* CEUS not performed or performed more than three months after CT or MRI'}, 'identificationModule': {'nctId': 'NCT05772403', 'briefTitle': 'Contrast Enhanced Ultrasound (CEUS) in Atypical Liver Nodules in Patients With Chronic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Contrast-enhanced Ultrasound (CEUS) Improves Characterization of Atypical Liver Nodules in Patients With Chronic Liver Disease', 'orgStudyIdInfo': {'id': '4288'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CEUS', 'type': 'DIAGNOSTIC_TEST', 'description': 'CEUS for atypical liver nodules'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Fondazione Policlinico A Gemelli Irccs', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}