Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01231269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2010-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Whole-body Diffusion-weighted Magnetic Resonance Imaging for Staging and Treatment Prediction of Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2010-10-28', 'studyFirstSubmitQcDate': '2010-10-29', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease stage', 'timeFrame': '4 years', 'description': 'Lesions are characterized as benign or malignant based on signal intensity and ADC values, enabling correct determination of tumor extent (staging).'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '6 years', 'description': 'We will investigate whether there is a correlation between ADC and signal intensity changes during therapy and progression free survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lymphoma', 'Hodgkin Lymphoma', 'Non-Hodgkin Lymphoma (Follicular, Diffuse B-cel Lymphoma, PTLD and Mantle Cel Lymphoma)']}, 'referencesModule': {'references': [{'pmid': '33817648', 'type': 'DERIVED', 'citation': 'De Paepe KN, Van Keerberghen CA, Agazzi GM, De Keyzer F, Gheysens O, Bechter O, Wolter P, Dierickx D, Janssens A, Verhoef G, Oyen R, Koole M, Vandecaveye V. Quantitative Whole-Body Diffusion-weighted MRI after One Treatment Cycle for Aggressive Non-Hodgkin Lymphoma Is an Independent Prognostic Factor of Outcome. Radiol Imaging Cancer. 2021 Mar 26;3(2):e200061. doi: 10.1148/rycan.2021200061. eCollection 2021 Mar.'}]}, 'descriptionModule': {'briefSummary': 'Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted-images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native DWI images and low ADC. Several studies indicate the value of DWI for differentiation of benign and malignant lymph nodes, detection of tumor recurrence and for ADC-based prediction of treatment outcome in various solid tumours (Koh DM et al, Am J Roentgenol 2007).\n\nPatients with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and PTLD) will be included in the study. These patients will receive a WB-DWI scan before treatment, once or twice during treatment (depending on the type of lymphoma) and after the completion of the treatment. The MRI scan will be performed on a 3 Tesla-MRI system without contrast administration and without exposing the patient to radiation.\n\nWhole body diffusion-weighted images will be prospectively interpreted by two experienced radiologists, blinded to all clinical and imaging data. Findings will be correlated to FDG-18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose , biopsies performed in clinical routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up.\n\nThe purpose of this study is:\n\n* to evaluate Whole body diffusion-weighted imaging for staging of lymphoma\n* to evaluate Whole body diffusion-weighted imaging as an early predictive biomarker for treatment outcome\n* to evaluate Whole body diffusion-weighted imaging for differentiating residual tumor from post therapy changes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* every patient with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cel lymphoma, mantle cell lymphoma, follicular lymphoma and PTLD)\n\nExclusion Criteria:\n\n* patient with general contraindications for MRI (pacemaker, claustrophobia, etc.)\n* patients with a type of lymphoma other than those described in the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01231269', 'briefTitle': 'Whole-body Diffusion-weighted Magnetic Resonance Imaging for Staging and Treatment Prediction of Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Whole-body Diffusion-weighted Magnetic Resonance Imaging for Staging and Treatment Prediction of Lymphoma', 'orgStudyIdInfo': {'id': 'S51160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI', 'description': 'diffusion-weighted MRI', 'interventionNames': ['Other: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': 'MRI scan without administration of contrast/without radiation', 'armGroupLabels': ['MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'vincent vandecaveye, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}