Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 10:48 PM
Study NCT ID:
NCT06362304
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2024-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
99mTc-CNDG SPECT/CT in Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SUVmax', 'timeFrame': '1month', 'description': '1\\. Diagnostic consistency evaluation of 99mTc-CNDG and 18F-FDG; 2.Correlation of SUV value of 99mTc-CNDGwith tumor type'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracranial Tumor']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the value of 99mTc-CNDG for diagnosis of brain tumors by comparing it with 18F-FDG-PET. The main questions it aims to answer are:\n\n1. What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?\n2. What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?\n\nParticipants will:\n\nReceive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical diagnosis of brain tumor;\n* Be at least 18 years old;\n* The final pathological results could be obtained by surgery or biopsy;\n* Informed consent and the ability to be followed up;\n* Those who did not meet the exclusion criteria.\n\nExclusion Criteria:\n\n* Insulin-dependent diabetes mellitus or fasting blood glucose \\>7 mmol/L before 99mTc-CNDG injection;\n* Severe liver or kidney disease (serum creatinine level \\>3.0mg/dL or any liver enzyme level ≥ 5 times the upper limit of normal);\n* Severe hypersensitivity or hypersensitivity to radiocontrast agents;\n* Claustrophobia (inability to undergo SPECT/CT or PET/CT scans);\n* Patients receiving radiotherapy and chemotherapy;\n* Being pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06362304', 'briefTitle': '99mTc-CNDG SPECT/CT in Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Application of 99mTc-CNDG SPECT/CT Imaging in the Diagnosis of Brain Tumors', 'orgStudyIdInfo': {'id': '2024-DG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intracranial tumor', 'interventionNames': ['Diagnostic Test: 99mTc-CNDG SPECT/CT']}], 'interventions': [{'name': '99mTc-CNDG SPECT/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'FDG-PET and 99mTc-CNDG will be performed within 2 weeks before surgery.', 'armGroupLabels': ['intracranial tumor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaohui Zhu', 'role': 'CONTACT', 'email': '13611093752@163.com', 'phone': '010-69154241'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhaohui Zhu', 'role': 'CONTACT', 'email': '13611093752@163.com', 'phone': '01069154241'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}