Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT05659433
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2022-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012186', 'term': 'Retroperitoneal Neoplasms'}], 'ancestors': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-12-03', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with a biopsy sample adequate for pathology interpretation', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of patients requiring a second biopsy due to prior inadequate sampling', 'timeFrame': '6 weeks'}, {'measure': 'Number of patients with procedural-related adverse events', 'timeFrame': 'One week', 'description': 'Bleeding, hematoma, puncture-site infection, prolonged hospitalisation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous biopsy', 'Contrast-enhanced ultrasonography', 'CEUS', 'Retroperitoneal neoplasms'], 'conditions': ['Retroperitoneal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate).\n\nRationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area.\n\nAims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events.\n\nMethods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy.\n\nThe diagnostic accuracy, need for repeat biopsy, and adverse events were noted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with retroperitoneal tumors with indication for percutaneous biopsy\n\nExclusion Criteria:\n\n* Tumors inaccessible for ultrasound guided biopsy\n* Standard contraindications for biopsy (altered coagulation tests, poor performance status)\n* Lack of written informed consent'}, 'identificationModule': {'nctId': 'NCT05659433', 'briefTitle': 'Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEUS-PBRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B-mode Ultrasound-guided Biopsy', 'interventionNames': ['Procedure: B-mode US-guided percutaneous biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Contrast-enhanced Ultrasound-guided Biopsy', 'interventionNames': ['Procedure: CEUS-guided percutaneous biopsy']}], 'interventions': [{'name': 'CEUS-guided percutaneous biopsy', 'type': 'PROCEDURE', 'description': 'A standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized)', 'armGroupLabels': ['Contrast-enhanced Ultrasound-guided Biopsy']}, {'name': 'B-mode US-guided percutaneous biopsy', 'type': 'PROCEDURE', 'description': 'Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement', 'armGroupLabels': ['B-mode Ultrasound-guided Biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400162', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'facility': 'Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'overallOfficials': [{'name': 'Zeno Spârchez, MD, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rareș Crăciun', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}