Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-07 @ 10:06 PM
Study NCT ID:
NCT05397860
Status:
UNKNOWN
Last Update Posted:
2022-06-15
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], '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'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-11', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local tumor progression rate', 'timeFrame': '12 months after radiofrequency ablation (RFA)', 'description': 'Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level'}], 'secondaryOutcomes': [{'measure': 'Success rate of cone-unit ablation', 'timeFrame': 'Immediately after radiofrequency ablation (RFA)', 'description': 'The cone-unit ablation is defined as complete ablation of tumor with safety margin and occlusion of the 4th or 5th branches of portal vein.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiofrequency ablation', 'Gradual radiofrequency energy increment', 'Cone-unit ablation'], 'conditions': ['Hepatocellular Carcinoma', 'Liver Cirrhosis', 'Chronic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '39169297', 'type': 'DERIVED', 'citation': 'Hwang S, Kim JH, Yu SJ, Lee JM. Incremental high power radiofrequency ablation with multi-electrodes for small hepatocellular carcinoma: a prospective study. BMC Gastroenterol. 2024 Aug 21;24(1):280. doi: 10.1186/s12876-024-03358-w.'}, {'pmid': '37605251', 'type': 'DERIVED', 'citation': 'Kim JH, Kim HS, Yoon JH, Joo I, Yoon JH, Kim YJ, Yu SJ, Lee JM. Anatomical ablation for small hepatocellular carcinomas using multiple applicators: a preliminary study. Cancer Imaging. 2023 Aug 21;23(1):78. doi: 10.1186/s40644-023-00597-0.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child-Pugh Class A or B\n* chronic hepatitis B or liver cirrhosis\n* contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date\n* clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm\n\nExclusion Criteria:\n\n* number of HCC, equal or more than 3\n* largest tumor size over 4 cm\n* Child-Pugh class C\n* presence of vascular invasion by HCC\n* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%\n* presence of extrahepatic metastasis'}, 'identificationModule': {'nctId': 'NCT05397860', 'briefTitle': 'Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study', 'orgStudyIdInfo': {'id': '1909-086-1064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )', 'description': 'Patients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).', 'interventionNames': ['Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes']}], 'interventions': [{'name': 'Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes', 'type': 'PROCEDURE', 'description': 'Radiofrequency ablation (RFA) will be performed by using multi-VIVA generator and Octopus electrodes. Three electrodes will be placed on the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF) will be applied to two of three electrodes at the same time for about 6 to 30 minutes depending on the tumor size. The temperature will be maintained at 90-100 °C. The RF energy will starts at 60 watts and increase by 10 watts every 30 seconds for the first 3 minutes, and then increases gradually by 10 watts per minute after reaching 100 watts.', 'armGroupLabels': ['Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Hee Lee, RN', 'role': 'CONTACT', 'email': 'redlion55@naver.com', 'phone': '82-2-2072-4177'}, {'name': 'Jae Hyun Kim, MD', 'role': 'CONTACT', 'email': 'yyssaa21@gmail.com', 'phone': '82-2-2072-2519'}, {'name': 'Jeong Min Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyun Hee Lee', 'role': 'CONTACT', 'email': 'redlion55@naver.com', 'phone': '82-2-2072-4177'}, {'name': 'Jae Hyun Kim, M.D.', 'role': 'CONTACT', 'email': 'yyssaa21@gmail.com', 'phone': '82-2-2072-2519'}], 'overallOfficials': [{'name': 'Jeong Min Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Starmed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Min Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}