Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
Study NCT ID:
NCT06725706
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2024-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beta Amyloid PET/CT in Various Aβ-Related Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized uptake value (SUV)', 'timeFrame': '30 days', 'description': 'Standardized uptake value (SUV) of 18F-92/AV45, 11C-PIB for each target lesion of subject or suspected primary tumor or/and metastasis.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic efficacy', 'timeFrame': '30 days', 'description': 'The sensitivity, specificity and accuracy of Aβ PET/CT were calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'MRI', 'Beta-Amyloid'], 'conditions': ['Amyloid', 'Beta-Amyloid', 'Neurodegenerative Diseases']}, 'descriptionModule': {'briefSummary': 'To evaluate the potential usefulness of 18F-92/AV45, 11C-PIB positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.', 'detailedDescription': 'Subjects with various Tau-related disease patients underwent 18F-92/AV45, 11C-PIB PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-92/AV45, 11C-PIB PET/CT were calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Aβ PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Aβ PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n\\- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT06725706', 'briefTitle': 'Beta Amyloid PET/CT in Various Aβ-Related Disease', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University'}, 'officialTitle': 'Beta Amyloid PET/CT in Various Aβ-Related Disease', 'orgStudyIdInfo': {'id': 'TJMUGH-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Group Assignment', 'description': 'Each subject receive a single intravenous injection of 18F-92/AV45, 11C-PIB and undergo PET/CT or MRI imaging within the specificed time.', 'interventionNames': ['Diagnostic Test: 18F-92/AV45, 11C-PIB']}], 'interventions': [{'name': '18F-92/AV45, 11C-PIB', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each subject receive a single intravenous injection of 18F-92/AV45, 11C-PIB and undergo PET/CT or MRI imaging within the specificed time.', 'armGroupLabels': ['Single Group Assignment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Xie, PhD', 'role': 'CONTACT', 'email': 'ahxq1980@163.com', 'phone': '+8613721108043'}, {'name': 'Qiang Xie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of University of Science and Technology of China', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Chang, MD', 'role': 'CONTACT', 'email': 'cyneurology@163.com', 'phone': '+8618210830630'}, {'name': 'Yan Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese PLA General Hospital,', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Wang, MD', 'role': 'CONTACT', 'email': 'macrossplusvoices@163.com', 'phone': '+8618702292537'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Ying Wang, MD', 'role': 'CONTACT', 'email': 'macrossplusvoices@163.com', 'phone': '+8618702292537'}, {'name': 'Li Cai, MD', 'role': 'CONTACT', 'email': 'xcl242004@126.com', 'phone': '+862260362190'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Shaobo Yao, PhD', 'investigatorAffiliation': 'Tianjin Medical University'}}}}