Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-09 @ 1:51 AM
Study NCT ID:
NCT06419361
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2024-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2024-05-14', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic efficacy', 'timeFrame': '15 days', 'description': 'The sensitivity, specificity, and accuracy of \\[68Ga\\]Ga-Sa-DABI-4 PET'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stimulator of Interferon Gene', 'Cancer', 'Positron Emission Tomography']}, 'descriptionModule': {'briefSummary': 'Stimulator of interferon gene (STING) protein plays a vital role in the immune surveillance of tumor microenvironment. Monitoring STING expression in tumors benefits the relevant STING therapy. This study will investigate the safety, biodistribution and potential usefulness of a novel 68Ga-labeled agonist (\\[68Ga\\]Ga-Sa-DABI-4) for noninvasive positron emission tomography (PET) imaging of STING expression in the tumor microenvironment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Signed informed consent.\n3. Patients with suspected or newly diagnosed or previously malignant disease.\n\nExclusion Criteria:\n\n1. Patients with non-malignant disease.\n2. Patients with pregnancy.\n3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.\n4. Known or expected hypersensitivity to \\[68Ga\\]Ga-Sa-DABI-4 or any of its components.\n5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.'}, 'identificationModule': {'nctId': 'NCT06419361', 'briefTitle': '[68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': '[68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients', 'orgStudyIdInfo': {'id': 'CYYY-KY-2024-049-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[68Ga]Ga-Sa-DABI-4', 'description': 'Patients will receive a single administration of \\[68Ga\\]Ga-Sa-DABI-4.', 'interventionNames': ['Drug: [68Ga]Ga-Sa-DABI-4']}], 'interventions': [{'name': '[68Ga]Ga-Sa-DABI-4', 'type': 'DRUG', 'description': 'Each subject receives a single intravenous injection of \\[68Ga\\]Ga-Sa-DABI-4.', 'armGroupLabels': ['[68Ga]Ga-Sa-DABI-4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyang Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangxy@mail.bnu.edu.cn', 'phone': '023-89011755'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Xiaoyang Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangxy@mail.bnu.edu.cn', 'phone': '023-89011755'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiaoyang Zhang', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}