Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-30 @ 4:10 AM
Study NCT ID:
NCT06204835
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2039-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2024-01-03', 'studyFirstSubmitQcDate': '2024-01-03', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HCC lesions', 'timeFrame': 'During hepatocellular resection surgery.', 'description': 'Numbers of intraoperatively detected hepatocellular carcinoma lesions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and finally help the accurate surgical resection.\n\nThe main purposes of this study include:\n\n1. To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe.\n2. To validate the safety and effectiveness of the proposed ITGA6 targeting probes for clinical application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have been diagnosed with hepatocellular carcinoma.\n2. Planned to receive hepatectomy.\n3. Liver function Child-Pugh A.\n4. ITGA6 was validated highly expressed preoperatively.\n5. Aged 18 to 80, and the expected lifetime is longer than 6 months.\n6. Approved to sign the informed consent.\n\nExclusion Criteria:\n\n1. Allergic to Cy7.\n2. Enrolled in other trials in the past 3 months.\n3. Another malignant tumor was found.\n4. Undesirable function of heart, lung, kidney, or any other organs.\n5. Unable to tolerate a hepatectomy.\n6. The researchers considered inappropriate to be included.'}, 'identificationModule': {'nctId': 'NCT06204835', 'briefTitle': 'ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Automation, Chinese Academy of Sciences'}, 'officialTitle': 'ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery of HCC Patients', 'orgStudyIdInfo': {'id': 'ITGARD7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RDCy7 Intraoperative Fluorescence', 'description': 'The patients will receive an injection of fluorophore (RDCy7) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection.', 'interventionNames': ['Drug: RD-Cy7 fluorophore']}], 'interventions': [{'name': 'RD-Cy7 fluorophore', 'type': 'DRUG', 'description': 'Fluorophore targeting ITGA6 that is overexpressed in HCC cells', 'armGroupLabels': ['RDCy7 Intraoperative Fluorescence']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojing Shi, Ph.D', 'role': 'CONTACT', 'email': 'shixiaojing2017@ia.ac.cn', 'phone': '13261798652'}], 'facility': 'Guangdong', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Luzhou', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojing Shi, PhD', 'role': 'CONTACT', 'email': 'shixiaojing2017@ia.ac.cn', 'phone': '13261798652'}], 'facility': 'Sichuan', 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}], 'centralContacts': [{'name': 'Xiaojing Shi, PhD', 'role': 'CONTACT', 'email': 'shixiaojing2017@ia.ac.cn', 'phone': '13261798652'}], 'overallOfficials': [{'name': 'Zhenhua Hu, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Automation, Chinese Academy of Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No publications available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Automation, Chinese Academy of Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhenhua Hu', 'investigatorAffiliation': 'Institute of Automation, Chinese Academy of Sciences'}}}}