Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 5:46 PM
Study NCT ID:
NCT05436093
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2022-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized uptake value（SUV）', 'timeFrame': '2 years', 'description': 'SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-ACN376） in solid tumor lesions by measuring SUV on PET/CT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to construct a noninvasive approach 68Ga-ACN376 PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Aged \\>18 years old; ECOG 0 or 1;\n* 2\\. Patients with solid tumors;\n* 3\\. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);\n* 4\\. life expectancy \\>=12 weeks.\n\nExclusion Criteria:\n\n* 1\\. Significant hepatic or renal dysfunction;\n* 2\\. Is pregnant or ready to pregnant;\n* 3\\. Cannot keep their states for half an hour;\n* 4\\. Refusal to join the clinical study;\n* 5\\. Suffering from claustrophobia or other mental diseases;\n* 6\\. Any other situation that researchers think it is not suitable to participate in the experiment.'}, 'identificationModule': {'nctId': 'NCT05436093', 'briefTitle': 'CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors', 'orgStudyIdInfo': {'id': '2022KT96'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-ACN376', 'description': 'Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-ACN376 PET/CT scan.', 'interventionNames': ['Drug: 18F-FDG']}], 'interventions': [{'name': '18F-FDG', 'type': 'DRUG', 'description': 'All study participants will undergo one 18F-FDG PET/CT scan.', 'armGroupLabels': ['68Ga-ACN376']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua Zhu', 'role': 'CONTACT', 'email': 'zhuhuabch@pku.edu.cn', 'phone': '010-88196495'}], 'facility': 'Beijing cancer hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hua Zhu', 'role': 'CONTACT', 'email': 'zhuhuabch@pku.edu.cn', 'phone': '010-88196495'}], 'overallOfficials': [{'name': 'Hua Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hua Zhu', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}