Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 11:57 AM
Study NCT ID:
NCT06701734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Translocator Protein PET Imaging Evaluate Neuroinflammation of the Chronic Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-11-16', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized Uptake Value', 'timeFrame': '2 years', 'description': 'Measures of specific binding of 18F-DPA-714 measures of specific binding of the tracer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chroinc Pain', 'PET', 'Microglial Activation']}, 'descriptionModule': {'briefSummary': "Chronic pain is a major public health issue, which seriously affects patients' quality of life. Neuroinflammation is an important mechanism resulting in chronic pain. Translocator protein (TSPO) has served as a marker of microglial activation and neuroinflammation. 18F-DPA714, a tracer targeted TSPO, can be used to evaluate the microglial activation and neuroinflammation in vivo by PET imaging.Recent and increasing studies have found changes in TSPO and its ligands in various chronic pain models. Reversing their expressions has been shown to alleviate chronic pain in these models, illustrating the effects of TSPO and its ligands.The investigators aim to explore the clinical feasibility used 18F-DPA714 PET imaging to monitor microglial cells activation of center nervous system in chronic pain patients. This study might reveal significant neuroinflammatory process in the center nervous system of the chronic pain patients. The results of this study might provide a new biomarker of disease pathological progression and indicates that TSPO-based therapy may become an alternative strategy for treating chronic pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic pain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic pain patients\n* Written informed consent was provided by the patients and their family\n\nExclusion Criteria:\n\n* history of head trauma ， epilepsy， claustrophobia, rheumatic or autoimmune diseases, psychiatric disorders, severe somatic diseases (neurological,cardiovascular, etc.),previous heart or brain surgery, substance abuse, inability to refrain from hypnotics, magnetic implants, pregnancy, lactation'}, 'identificationModule': {'nctId': 'NCT06701734', 'briefTitle': 'Targeted Translocator Protein PET Imaging Evaluate Neuroinflammation of the Chronic Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'Targeted Translocator Protein PET Imaging Evaluate Neuroinflammation of the Chronic Pain Patients', 'orgStudyIdInfo': {'id': 'Chronic_pain_DPA714 PET'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Qianqian Xue', 'role': 'CONTACT', 'email': 'xueqian124@163.com', 'phone': '+8618558799064'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weibing Miao, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Weibing Miao, PhD', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}