Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT05293405
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2022-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuroinflammatory PET Imaging in Autoimmune Encephalomyelitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004681', 'term': 'Encephalomyelitis, Autoimmune, Experimental'}], 'ancestors': [{'id': 'D020721', 'term': 'Nervous System Autoimmune Disease, Experimental'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2022-03-15', 'studyFirstSubmitQcDate': '2022-03-15', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TSPO expression level', 'timeFrame': 'Baseline', 'description': 'quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord'}, {'measure': 'TSPO expression level', 'timeFrame': '3 months after baseline', 'description': 'quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord'}, {'measure': 'TSPO expression level', 'timeFrame': '12 months after baseline', 'description': 'quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Encephalomyelitis']}, 'referencesModule': {'references': [{'pmid': '39294471', 'type': 'DERIVED', 'citation': 'Meng H, He L, Chunyu H, Zhou Q, Wang J, Qu Q, Hai W, Zhang Y, Li B, Zhang M, Chen S. 18F-DPA714 PET/MRI as a potential imaging tool for detecting possible antibody-negative autoimmune encephalitis: a prospective study. J Neurol. 2024 Dec;271(12):7592-7604. doi: 10.1007/s00415-024-12690-w. Epub 2024 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'Autoimmune encephalomyelitis is a heterogeneous group of central nervous system (CNS) autoimmune diseases characterized by the production of anti-neuron-associated autoantibodies which target neuronal surface proteins, synaptic receptors and intracellular antigens. MRI, as a current first-line imaging tool of CNS inflammation, is difficult to diagnose them because the majority of patients have normal MRI images, and only a few may show local signal or structural abnormalities (including inflammation, edema, or atrophy). The 18 kDa translocator protein (TSPO) expression in the CNS is upregulated in response to microglia activation. DPA-714 is high affinity for binding to TSPO, making 18F-labeled DPA-714 (18F-DPA-714) PET a very promising diagnostic imaging tool for neuroinflammation in patients with autoimmune encephalomyelitis.This study aims to explore the value of 18F-DPA-714 PET in the early diagnosis, therapeutic assessment and prognosis in patients with autoimmune encephalomyelitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Experimental group:\n\nInclusion criteria:\n\n1. Patients with onset for less than 2 years\n2. Serum autoantibody positive\n3. cognitive impairment or movement disorder diagnosed by two or more certified specialists.\n\nExclusion criteria:\n\n1. Patients who do not meet the clinicalălaboratory and imaging criteria of immune-related cognitive and movement disorders\n2. Medical history of surgery, trauma, stroke, tumor in brain or spine cord\n3. Alcoholism or drug dependence (addiction)\n4. Patients with pregnancy\n\nHealthy Volunteers group:\n\nInclusion criteria:\n\n1. able to understand the purpose of clinical research and test plan\n2. In the brain and spine cord MR assessment, it is judged as "normal"\n\nExclusion criteria:\n\n1. Any major mental illness; history of schizophrenia or schizoaffective disorder\n2. Any important neurological disease, such as cerebrovascular disease, inflammation or infectious disease, demyelinating disease, neurodegenerative disease, trauma in brain or spine cord\n3. History of alcohol or drug abuse/dependence\n4. Medical history of cardiac and lung disease, tumors, blood disease, poorly controlled chronic diseases\n5. Patients with pregnancy'}, 'identificationModule': {'nctId': 'NCT05293405', 'briefTitle': 'Neuroinflammatory PET Imaging in Autoimmune Encephalomyelitis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Neuroinflammatory Imaging Using TSPO PET Tracer in Paients With Autoimmune Encephalomyelitis', 'orgStudyIdInfo': {'id': '(2021)CER(375)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients Group', 'interventionNames': ['Diagnostic Test: 18F-DPA-714 PET']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy Volunteers Group', 'interventionNames': ['Diagnostic Test: 18F-DPA-714 PET']}], 'interventions': [{'name': '18F-DPA-714 PET', 'type': 'DIAGNOSTIC_TEST', 'description': 'TSPO expression are quantitatively analyzed in all brain regions or spinal cord using 18F-DPA-714 PET', 'armGroupLabels': ['Healthy Volunteers Group', 'Patients Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Zhang, Dr.', 'role': 'CONTACT', 'email': 'zm11518@rjh.com.cn', 'phone': '0086-21-64370045'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}