Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-30 @ 9:22 PM
Study NCT ID:
NCT02928861
Status:
UNKNOWN
Last Update Posted:
2016-10-10
First Post:
2016-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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': {'phases': ['NA'], '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': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2 year progression-free survival', 'timeFrame': 'up to 2 years after initial diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Positron-Emission Tomography', 'Prognosis'], 'conditions': ['Lymphoma, Large B-Cell, Diffuse']}, 'referencesModule': {'references': [{'pmid': '37114393', 'type': 'DERIVED', 'citation': 'Yuan T, Chen X, Zhang Y, Wei M, Zhu H, Yang Z, Wang X. A novel prognostic index for diffuse large B-cell lymphoma combined baseline metabolic tumour volume with clinical and pathological risk factors. Nucl Med Commun. 2023 Jul 1;44(7):622-630. doi: 10.1097/MNM.0000000000001701. Epub 2023 Apr 28.'}, {'pmid': '35530320', 'type': 'DERIVED', 'citation': 'Yuan T, Zhang Y, Chen X, Wei M, Zhu H, Song Y, Yang Z, Zhu J, Wang X. Risk Assessment in Diffuse Large B-Cell Lymphoma by Combining Baseline Metabolic Tumor Volume and Peking Criteria When Evaluating Series 18F-Fluorodeoxyglucose Positron Emission Tomography Scans. Front Oncol. 2022 Apr 21;12:876581. doi: 10.3389/fonc.2022.876581. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of diffuse large B-cell lymphoma can predict disease progression', 'detailedDescription': 'In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold (1.6 fold of liver SUVmax) or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in DLBCL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. newly diagnosed DLBCL;\n2. treated using an anthracycline-containing regimen with or without rituximab;\n3. minimal follow-up at 6 months after the completion of first-line treatment;\n4. complete medical history and clinicopathological data\n\nExclusion Criteria:\n\n1. secondary malignant disease;\n2. serious infection or inflammation (e.g., HIV);\n3. primary central nervous system lymphoma;\n4. hepatic or renal dysfunction.'}, 'identificationModule': {'nctId': 'NCT02928861', 'briefTitle': '18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': '18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'XW-DLBCL-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-FDG PET/CT-based prognostic model', 'description': 'The new prognostic model is based on 18F-FDG PET/CT scans, and combined with clinical and pathological prognostic factors.', 'interventionNames': ['Device: 18F-FDG PET/CT']}], 'interventions': [{'name': '18F-FDG PET/CT', 'type': 'DEVICE', 'description': '18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was \\<200 mg/ dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post- injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10 min/bed).', 'armGroupLabels': ['18F-FDG PET/CT-based prognostic model']}]}, '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 10-88196364'}, {'name': 'Yuewei Zhang', 'role': 'CONTACT', 'email': 'zhang_yue_wei@126.com'}], 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuejuan Wang, MD', 'role': 'CONTACT', 'email': 'xuejuan_wang@hotmail.com', 'phone': '86 10-88196364'}], '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 10-88196364'}], 'overallOfficials': [{'name': 'Xuejuan Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Nuclear Medicine', 'investigatorFullName': 'Xuejuan Wang,MD', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}