Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-30 @ 2:29 PM
Study NCT ID:
NCT05638256
Status:
UNKNOWN
Last Update Posted:
2022-12-06
First Post:
2022-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-labeled NY104 PET Imaging in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], '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': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-27', 'studyFirstSubmitDate': '2022-11-27', 'studyFirstSubmitQcDate': '2022-11-27', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of tissue distribution of 68Ga-NY104', 'timeFrame': '1 year', 'description': 'Biodistribution of 68Ga-NY104 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY104 PET Imaging in patients with Renal Cell Carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients voluntarily signed informed consent;\n2. Age 18-75, male or female;\n3. Patients diagnosed with renal cell carcinoma confirmed by histopathology or cytology;\n4. At least one measurable solid lesion has been examined according RECIST1.1 standard;\n5. ECOG score 0\\~3; Life expectancy of at least 3 months;\n\nExclusion Criteria:\n\n1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;\n2. Patients with systemic or locally severe infections, or other serious coexisting diseases;\n3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;\n4. Patients with autoimmune diseases, including rheumatoid arthritis;\n5. Inadequate control of arrhythmias, including atrial fibrillation;\n6. Uncontrolled hypertension;\n7. Patients with allergies or allergies to any component of the imaging agent or antibody;\n8. Patients who cannot undergo PET/CT imaging scan;\n9. Syphilis, HBV, HCV, or HIV positive subjects;\n10. Male and female subjects of reproductive age cannot take effective contraceptive measures;\n11. Pregnant or lactating women;\n12. Patients with a history of mental illness or related conditions;\n13. Other subjects considered unsuitable by researchers.'}, 'identificationModule': {'nctId': 'NCT05638256', 'briefTitle': '68Ga-labeled NY104 PET Imaging in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Jiangnan University'}, 'officialTitle': '68Ga-labeled NY104 PET Imaging in Patients', 'orgStudyIdInfo': {'id': 'LS2020003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-NY104', 'interventionNames': ['Drug: 68Ga-NY104']}], 'interventions': [{'name': '68Ga-NY104', 'type': 'DRUG', 'description': 'Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY104', 'armGroupLabels': ['68Ga-NY104']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214000', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunjing Yu', 'role': 'CONTACT', 'email': 'ycj_wxd1978@163.com', 'phone': '15312238622'}], 'facility': 'Affiliated Hospital of Jiangnan University', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}], 'centralContacts': [{'name': 'Chunjing Yu', 'role': 'CONTACT', 'email': 'ycj_wxd1978@163.com', 'phone': '15312238622'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Jiangnan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Chunjing Yu', 'investigatorAffiliation': 'Affiliated Hospital of Jiangnan University'}}}}