Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT06086327
Status:
UNKNOWN
Last Update Posted:
2023-10-17
First Post:
2023-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of 68Ga-Pentixafor PET/CT for Thymoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013945', 'term': 'Thymoma'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597686', 'term': '68Ga-pentixafor'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SUVmax and SUVmean', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'SUVsof focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVs of the blood pool and muscle are defined as the background activity on the condition that there is no focally hypermetabolic disease.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic value', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Diagnostic value of 68Ga-Pentixafor PET/CT for thymoma in comparison with 18F-FDG PET/CT or CT or MRI.'}, {'measure': 'Diagnostic value in special type of thymoma', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Diagnostic value of 68Ga-Pentixafor PET/CT in special type thymoma (A\\\\AB\\\\B\\\\C subtypes)'}, {'measure': 'Diagnostic value in thymoma and other masses', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Diagnostic value of 68Ga-Pentixafor PET/CT in thymoma and other anterior mediastinal mass.'}, {'measure': 'CXCR4 expression and SUV', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Correlation between CXCR4 expression and SUV in PET'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thymoma']}, 'referencesModule': {'references': [{'pmid': '39887860', 'type': 'DERIVED', 'citation': "Gao X, Peng X, Wang R, Qian Z, Zhou X, Zhu Z, Chen Y. An Occult Primary Thymic Mucosa-Associated Lymphoid Tissue Lymphoma With Sjogren's Syndrome Revealed by CXCR4 Targeted 68Ga-Pentixafor PET/CT. J Cell Mol Med. 2025 Feb;29(3):e70248. doi: 10.1111/jcmm.70248."}]}, 'descriptionModule': {'briefSummary': 'Chemokine receptor CXCR4 was expressed in T cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of thymoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, distinguish evaluation for thymoma.', 'detailedDescription': 'Thymoma is 1 rare type of tumor developed on the thymic epithelium; patients with thymoma also might have myasthenia gravis (MG). Because of the scarcity and complexity of MG-associated thymoma, its pathogenesis and etiology still remain unclear nowadays. The expression of C-X-C chemokine receptor type 4 (CXCR4) is absent or low in most healthy tissues but highly expressed in various types of tumors. CXCR4 might contribute to the clinical cancer progression, and CXCR4 could be a valuable prognostic biomarker in the therapy of MG-associated thymoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected or confirmed untreated thymoma patients\n* signed written consent.\n\nExclusion Criteria:\n\n* pregnancy\n* breastfeeding\n* known allergy against Pentixafor\n* any medical condition that in the opinion of the investigator,may\n* significantly interfere with study compliance.'}, 'identificationModule': {'nctId': 'NCT06086327', 'briefTitle': 'Application of 68Ga-Pentixafor PET/CT for Thymoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Chemokine Receptor CXCR4-targeting PET Imaging for Thymoma', 'orgStudyIdInfo': {'id': 'PUMCH-CXCR4-thymoma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-Pentixafor, PET/CT', 'description': 'Inject 68Ga-Pentixafor and then perform PET/CT scan.', 'interventionNames': ['Drug: 68Ga-Pentixafor']}], 'interventions': [{'name': '68Ga-Pentixafor', 'type': 'DRUG', 'otherNames': ['68Ga-CXCR4'], 'description': 'Intravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions of thymoma by PET/CT.', 'armGroupLabels': ['68Ga-Pentixafor, PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaohui Zhu, MD', 'role': 'CONTACT', 'email': '13611093752@163.com', 'phone': '+8613611093752'}], 'facility': 'Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Rongxi Wang', 'role': 'CONTACT', 'email': 'zhzwrx.123@163.com', 'phone': '+8615584172170'}, {'name': 'Zhaohui Zhu', 'role': 'CONTACT', 'email': '13611093752@163.com', 'phone': '+8613611093752'}], 'overallOfficials': [{'name': 'Zhaohui Zhu', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}