Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-29 @ 4:05 PM
Study NCT ID:
NCT05004961
Status:
UNKNOWN
Last Update Posted:
2023-03-03
First Post:
2021-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Performance of Multi-tracer Multimodality PET in Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2021-08-07', 'studyFirstSubmitQcDate': '2021-08-07', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SUVmax', 'timeFrame': '150 days', 'description': 'Standardized uptake value of 68Ga/ 18F-NOTA-FAPI 04 for target lesion of subject or suspected tumor in each time point window (SUV)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positron-Emission Tomography', 'Lymphoma'], 'conditions': ['Positron-Emission Tomography']}, 'referencesModule': {'references': [{'pmid': '36994205', 'type': 'DERIVED', 'citation': 'Chen X, Yuan T, Wei M, Yu B, Zhou N, Zhu H, Yang Z, Wang X. Diagnostic performance of integrated whole-body 18F-FDG PET/MRI for detecting bone marrow involvement in indolent lymphoma: Comparison with 18F-FDG PET or MRI alone. Front Oncol. 2023 Mar 13;13:1136687. doi: 10.3389/fonc.2023.1136687. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Investigating the performance of Multi-tracer Multimodality PET in lymphoma', 'detailedDescription': 'In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by different molecular probe such as FDG, FAPI-04 via multimodality PET (PET/CT and PET/MR). Our Previous studies have shown that uptake of FAPI-04 on PET may be an indicator of lymphoma lesions. The combination of PET with CT/MR allows for depicting metabolic, functional and morphological properties of tumor lesions at the same time, which is therefore an alternative attractive pairing for diagnosis, staging and prognosis of lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients pathologically diagnosed as lymphoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologically diagnosed as lymphoma;\n* Written informed consent for receiving FAPI-04 PET examinations.\n* cancer planned chemotherapy or immunotherapy scheme.\n* expected survival ≥ 12 weeks\n\nExclusion Criteria:\n\n* cannot lie supine for half an hour;\n* refuse to join the clinical researcher;\n* severe liver or kidney dysfunction\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT05004961', 'briefTitle': 'The Performance of Multi-tracer Multimodality PET in Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'The Performance of Multi-tracer Multimodality PET in Lymphoma', 'orgStudyIdInfo': {'id': 'XW-MMPET-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuejuan Wang, MD', 'role': 'CONTACT', 'email': 'xuejuan_wang@hotmail.com', 'phone': '86 10-88196363'}], 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xuejuan Wang, MD', 'role': 'CONTACT', 'email': 'xuejuan_wang@hotmail.com', 'phone': '86 010 88196363'}], 'overallOfficials': [{'name': 'Yang Zhi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xuejuan Wang', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}