Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT07105956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SUVmax of lesion uptake value', 'timeFrame': '60min after administration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer's Disease (AD)']}, 'descriptionModule': {'briefSummary': "Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium \\[68Ga\\]-DOTA-HK-011 in neuroinflammation imaging of Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants were recruited through hospital electronic records and community health centers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Volunteer for the trial, with the patient or their legal guardian signing the informed consent form.\n* Volunteers are not limited by gender, and the age range is from 18 to 75 years old, including both ends.\n* The patient is diagnosed with Alzheimer's disease (AD), supported by a positive amyloid PET scan.\n* The patient has completed Tau PET scan.\n\nExclusion Criteria:\n\n* Individuals with a history of allergy to drugs chemically or biologically similar to TSPO, a history of atopy, or currently suffering from allergic diseases.\n* Use of anti-inflammatory drugs, including corticosteroids and immunosuppressants, within the past 14 days, which may interfere with the accuracy of inflammation imaging.\n* Presence of other coexisting neurological diseases, such as stroke, Parkinson's disease, brain tumors, or mental disorders, including depressive disorder and schizophrenia.\n* Severe cardiac, pulmonary, hepatic, or renal dysfunction, or uncontrolled systemic diseases; 5. Presence of metal implants contraindicated for MRI, including but not limited to cardiac pacemakers, artificial heart valves, and metal stents.\n* Claustrophobia or inability to tolerate prolonged examinations.\n* Pregnant women (defined as those with a positive urine pregnancy test) or breastfeeding women.\n* Patients whose physical condition is unsuitable for radioactive tracer-based imaging examinations.\n* Other circumstances deemed unsuitable for participation in the trial by the researcher."}, 'identificationModule': {'nctId': 'NCT07105956', 'briefTitle': "Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.", 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': "Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Alzheimer's Disease.", 'orgStudyIdInfo': {'id': 'KY20250624-06-KS-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jingasu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Feng Wang', 'role': 'CONTACT', 'email': 'fengwangcn@hotmail.com', 'phone': '+8602552271491'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Feng Wang', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}