Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 12:19 AM
Study NCT ID:
NCT06876805
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2025-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Ceus in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CEUS diagnostic accuracy', 'timeFrame': '2 years', 'description': 'CEUS diagnostic accuracy in determining the nature of focal liver lesions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CEUS', 'Ultrasound', 'Liver', 'HCC'], 'conditions': ['Focal Liver Lesion']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine the accuracy of CEUS in characterizing (as benign or malignant) focal liver lesions for which CT, MRI and/or PET have not been conclusive.', 'detailedDescription': 'The study conducted will be a non-profit, observational, non-pharmacological, cross-sectional, but also partly cohort, retrospective and prospective study. The study is cross-sectional in nature, but will require 6 months of follow-up to evaluate the gold standard reference outcome in patients diagnosed with a benign pathology that does not require further investigations, and in patients with suspected malignant lesion for which histological diagnosis has not been performed on biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who have previously resulted positive to CT, MRI and/or PET scans for liver lesions but with no information on the nature of the lesion and that will undero CEUS for further characterization of the lesion(s) will be consecutively enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* CEUS performed performed in the last 6 months a CT, MRI and/or PET not decisive in characterizing a liver lesion.\n* Obtaining informed consent.\n\nExclusion Criteria:\n\n* Technical impossibility to perform the ultrasound evaluation.\n* Documented allergy to the ultrasound contrast medium.'}, 'identificationModule': {'nctId': 'NCT06876805', 'acronym': 'InFoLIL', 'briefTitle': 'The Role of Ceus in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'The Role of Contrast Enhanced Ultrasond (Ceus), in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods', 'orgStudyIdInfo': {'id': 'InFoLIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients with focal liver lesions indeterminated at II level imaging methods', 'interventionNames': ['Diagnostic Test: CEUS or Contrast enhanced Ultrasound']}], 'interventions': [{'name': 'CEUS or Contrast enhanced Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Contrast enhanced ultrasound'], 'description': 'CEUS performed as normal clinical practice', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carla Serra, PhD', 'role': 'CONTACT', 'email': 'carla.serra@aosp.bo.it', 'phone': '+390512143270'}], 'facility': "Policlinico Sant'Orsola Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Carla Serra, PhD', 'role': 'CONTACT', 'email': 'carla.serra@aosp.bo.it', 'phone': '+390512143270'}], 'overallOfficials': [{'name': 'Carla Serra, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}