Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT06579833
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Histotripsy (HistoSonics®) for Liver Tumours
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': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in tumour features', 'timeFrame': 'up to 36 months', 'description': 'Changes in tumour size and volume before and after intervention'}, {'measure': 'Post procedure adverse events and complication', 'timeFrame': 'The whole duration of hospital stay, normally 3 days on average', 'description': 'Post procedure adverse events and complication'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver tumour'], 'conditions': ['Liver Tumour']}, 'descriptionModule': {'briefSummary': 'Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. This study will enrol 20 patients with liver tumours (be it primary or secondary liver tumours), monitor their post-operative adverse events, and study the changes in tumour size and volume after treatment. Histotripsy will be performed under general anaesthesia, with real-time monitoring by ultrasound, and deliver high-intensity ultrasound waves in single session or multiple sessions. Similar to other minimal invasive treatments, patients will be admitted 1 day prior, then receive Histotripsy on the next day and stay overnight for observation. Patients will be discharged on the 3rd day if unremarkable. During the hospital stay, blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fit for general anaesthesia\n* Liver tumour size \\< 10cm\n* Solitary or multifocal\n* Primary liver tumour such as hepatocellular carcinoma or intrahepatic cholangiocarcinoma\n* Secondary liver tumour such as liver metastasis\n* Patients with operable or inoperable liver tumours\n* Liver transplant candidates awaiting for liver graft\n\nExclusion Criteria:\n\n* Refusal to take part in clinical trial\n* Child C liver cirrhosis\n* Not fit for general anaesthesia'}, 'identificationModule': {'nctId': 'NCT06579833', 'briefTitle': 'Histotripsy (HistoSonics®) for Liver Tumours', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Histotripsy (HistoSonics®) for Liver Tumours: a Phase II Safety and Efficacy Study', 'orgStudyIdInfo': {'id': 'UW24-442'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Histotripsy', 'description': 'Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures', 'interventionNames': ['Radiation: Histotripsy']}], 'interventions': [{'name': 'Histotripsy', 'type': 'RADIATION', 'otherNames': ['HistoSonics'], 'description': 'Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue.', 'armGroupLabels': ['Histotripsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Albert Chan, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Albert Chi Yan Chan', 'investigatorAffiliation': 'The University of Hong Kong'}}}}