Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 10:36 PM
Study NCT ID:
NCT06519760
Status:
RECRUITING
Last Update Posted:
2024-11-07
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-21', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma', 'timeFrame': '1 year', 'description': 'Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT'}, {'measure': 'The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors', 'timeFrame': '1 year', 'description': 'Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.'}], 'secondaryOutcomes': [{'measure': 'The dosimetry of 68Ga-C1', 'timeFrame': '1 year', 'description': 'Research on the dose distribution of 68Ga-C1 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software'}, {'measure': 'Quantitative evaluation of 68Ga-C1', 'timeFrame': '1 year', 'description': 'Evaluation of quantitative parameters of 68Ga-C1, such as time-activity curve.'}, {'measure': 'Correlation with pathological expression', 'timeFrame': '1 year', 'description': 'Analyze CAIX expression at the imaging level in combination with CAIX expression in pathological specimens'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carbonic Anhydrase IX', '68Ga-C1', 'PET-CT', 'Clear Cell Renal Cell Carcinoma'], 'conditions': ['Carbonic Anhydrase IX', 'PET-CT', 'Clear Cell Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1.\n\nResearchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.', 'detailedDescription': 'Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent；\n2. Age ≥18；\n3. Patients with confirmed or suspected clear cell renal cell carcinoma;\n4. Expected survival ≥6 months.\n\nExclusion Criteria:\n\n1. Renal mass is known to be a metastasis of another primary tumor;\n2. Have other malignancies that require treatment;\n3. Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks;\n4. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²;\n5. Pregnant and lactating women or female patients plan to become pregnant within 6 months;\n6. Uncontrolled psychiatric disorders;\n7. Vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).'}, 'identificationModule': {'nctId': 'NCT06519760', 'briefTitle': '68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Evaluation of Diagnostic Value of 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '2024#07-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-C1', 'description': 'Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.', 'interventionNames': ['Drug: 68Ga-C1']}], 'interventions': [{'name': '68Ga-C1', 'type': 'DRUG', 'otherNames': ['CAIX specific PET imaging'], 'description': '68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg', 'armGroupLabels': ['68Ga-C1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanyan Yu', 'role': 'CONTACT', 'email': 'bdyyll@126.com', 'phone': '+86 1066119025'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kan Gong', 'role': 'CONTACT', 'email': 'kan.gong@bjmu.edu.cn', 'phone': '(86)-010-83572075'}], 'overallOfficials': [{'name': 'Kan Gong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgeon', 'investigatorFullName': 'GONG Kan', 'investigatorAffiliation': 'Peking University First Hospital'}}}}