Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT06148233
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2023-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-19', 'studyFirstSubmitDate': '2023-11-19', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete PET imaging', 'timeFrame': '90mins from time of injection', 'description': "To assess the diagnostic value of \\[18F\\]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Positron Emission Tomography', 'Alzheimer Disease', 'Neurodegenerative Diseases']}, 'descriptionModule': {'briefSummary': "To explore the diagnostic value of \\[18F\\]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease. PET imaging with this PET tracer was used to assess the role and expression of CSF1R in AD and to evaluate the level and safety of abnormal present imaging."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-diseased controls:\n\n 1. Between 60 and 80 years of age; gender is not limited.\n 2. Cognitively normal as determined by the investigator through testing, with an MMSE score greater than 25 and no cognitive domain impairment. They had a negative Aβ image.\n 3. No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as determined by the investigator.\n 4. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.\n 5. Blood routine: white blood cell count (WBC) 4\\~10×109/L; platelet (PLT) 100\\~300×109/L; hemoglobin (HB) 120\\~160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; hepatic function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; Electrocardiogram: no significant abnormalities.\n 6. No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as confirmed by the investigator; no family history of neurodegenerative movement disorders, and no family history of neurological disorders related to movement disorders.\n 7. Willingness and ability to cooperate with all programs of this study.\n\nAD patients:\n\n1. Age between 60 and 80 years old; gender is not limited.\n2. Patients meet the 2011 NIA-AA diagnostic criteria for red AD patients and have positive Aβ images.\n3. Brain MRI supported the diagnosis of AD and there was no evidence of other neurological diseases.\n4. No neurological diseases, major chronic diseases, malignant tumors or acute infectious diseases, etc., as confirmed by the investigator.\n5. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.\n6. Blood routine: white blood cell count (WBC) 4\\~10×109/L; platelet (PLT) 100\\~300×109/L; hemoglobin (HB) 120\\~160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; hepatic function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; ECG: no significant abnormalities.\n7. No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as confirmed by the investigator; no family history of neurodegenerative movement disorders, and no family history of neurological disorders related to movement disorders.\n8. Willingness and ability to cooperate with all programs of this study.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from the study:\n\n 1. Severe hepatic or renal insufficiency;\n 2. Participation in other research protocols or clinical care within the past year, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.\n 3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.\n 4. History of serious surgery in the last month.\n 5. Participation in other clinical trials during the same period.'}, 'identificationModule': {'nctId': 'NCT06148233', 'briefTitle': "CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging", 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': "CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging", 'orgStudyIdInfo': {'id': 'KY2023-780'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "patients with Alzheimer's Disease", 'description': 'AD subjects recruited from geriatric wards or memory clinics.', 'interventionNames': ['Radiation: [18F]CSF-23']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitively normal control group', 'description': 'Cognitively normal subjects recruited from the community', 'interventionNames': ['Radiation: [18F]CSF-23']}], 'interventions': [{'name': '[18F]CSF-23', 'type': 'RADIATION', 'description': 'Intravenous injection of 1.8 MBq \\[0.05MCi\\]/kg of \\[18F\\]CSF-23 in a single dose.', 'armGroupLabels': ['Cognitively normal control group', "patients with Alzheimer's Disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yihui Guan, MD', 'role': 'CONTACT', 'email': 'guanyihui@hotmail.com', 'phone': '13764308300', 'phoneExt': '+86'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yihui Guan, MD', 'role': 'CONTACT', 'email': 'guanyihui@hotmail.com', 'phone': '13764308300', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Fang Xie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'YiHui Guan', 'investigatorAffiliation': 'Huashan Hospital'}}}}