Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04844112
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2021-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success rate of the fusion process', 'timeFrame': 'Immediately after fusion process', 'description': 'Absolute technical success rate of the fusion process'}, {'measure': 'Technical success rate of the overall RFA procedure', 'timeFrame': 'immediately after RFA procedure', 'description': 'Absolute technical success rate of the overall RFA compared to literature'}, {'measure': 'Rate of complete ablation of the tumor after 1 month clinical follow up', 'timeFrame': '1 month after the RFA procedure', 'description': 'Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature'}], 'secondaryOutcomes': [{'measure': 'Local tumor progression rate', 'timeFrame': 'During post procedural follow up to 5 years', 'description': 'Local tumor progression rate after follow up compared to literature'}, {'measure': 'Tumor visibility before and after the fusion process', 'timeFrame': '10 minutes after finishing planning USG', 'description': 'Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.'}, {'measure': 'Technical feasibility before and after the fusion process', 'timeFrame': '10 minutes after finishing planning USG', 'description': 'Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.'}, {'measure': 'Safety of the approach route before and after the fusion process', 'timeFrame': '10 minutes after finishing planning USG', 'description': 'Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiofrequency ablation', 'Fusion imaging'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.', 'detailedDescription': 'RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologic or typical imaging based diagnosis of HCC\n* Multiphase CT or MRI within 3 months ahead of procedure\n* No evidence of distant metastasis\n* No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet \\> 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number \\>4, largest tumor size \\> 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.\n\nExclusion Criteria:\n\n* Lack of multiphase CT or MRI withing 3 months ahead of procedure\n* RFA planned for palliative purpose\n* Diagnosed as non-HCC malignancy\n* Right hepatectomy state'}, 'identificationModule': {'nctId': 'NCT04844112', 'briefTitle': 'CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study', 'orgStudyIdInfo': {'id': '1506-015-677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'patients undergo routine conventional feasibility planning ultrasound, and clinical decision of RFA feasibility is made based on conventional planning ultrasound.\n\nThen additional planning ultrasound using automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.', 'interventionNames': ['Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation']}], 'interventions': [{'name': 'automatic CT/MRI-US fusion system guided radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'automatic CT/MRI-US fusion system guided radiofrequency ablation', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jeong Min Lee', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Min Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}