Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT02705118
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2015-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2016-03-05', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Registration accuracy', 'timeFrame': 'Immediately after RF ablation', 'description': 'Accuracy of imaging fusion (US and MRI)'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Within 48 hours after RF ablation', 'description': 'Completeness of tumor ablation'}, {'measure': 'Technical effectiveness', 'timeFrame': 'One month after RF ablation', 'description': 'Completeness of tumor ablation'}, {'measure': 'Registration time', 'timeFrame': 'Within 48 hours after RF ablation', 'description': 'Time required for registration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radiofrequency ablation', 'image fusion'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.', 'detailedDescription': '1. Patients will be randomized and assigned.\n2. For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured.\n3. For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured.\n\n3\\) After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques.\n\n5\\) After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 40-years old\n* Patients with hepatic malignancy who will underwent radiofrequency ablation\n\nExclusion Criteria:\n\n* Not using fusion imaging (CT guidance or fluoroscopic guidance)'}, 'identificationModule': {'nctId': 'NCT02705118', 'acronym': 'FAME-US', 'briefTitle': 'Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Evaluation of Performance of S-fusion for Radiofrequency Ablation of Hepatocellular Carcinoma: A Randomized, Prospective Study', 'orgStudyIdInfo': {'id': 'KC15DNSI0039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Automatic registration arm', 'description': 'Automatic registration for fusion imaging of US and MRI will be performed.\n\nAutomatic Imaging fusion of ultrasonography and MRI', 'interventionNames': ['Device: Automatic Imaging fusion of ultrasonography and MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual registration arm', 'description': 'Manual registration for fusion imaging of US and MRI will be performed.\n\nManual Imaging fusion of ultrasonography and MRI', 'interventionNames': ['Device: Manual Imaging fusion of ultrasonography and MRI']}], 'interventions': [{'name': 'Automatic Imaging fusion of ultrasonography and MRI', 'type': 'DEVICE', 'description': 'Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.', 'armGroupLabels': ['Automatic registration arm']}, {'name': 'Manual Imaging fusion of ultrasonography and MRI', 'type': 'DEVICE', 'description': 'Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.', 'armGroupLabels': ['Manual registration arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joon-Il Choi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JOON-IL CHOI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'JOON-IL CHOI', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}