Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-03-02 @ 12:31 AM
Study NCT ID:
NCT01780766
Status:
UNKNOWN
Last Update Posted:
2013-01-31
First Post:
2013-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2013-01-26', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'outcome', 'timeFrame': '5 years', 'description': 'correlation between early treatment response and outcome of the patient by measuring apparent diffusion coefficient'}], 'primaryOutcomes': [{'measure': 'Validation', 'timeFrame': '2 years', 'description': 'Validation of whole body MRI diffusion-weighted imaging in multiple myeloma at 3 Tesla MRI: correlation of the new MRI imaging technique (diffusion weighted imaging)to standard validated imaging technique (Computer Tomography and Magnetic Resonance Imaging)'}], 'secondaryOutcomes': [{'measure': 'Therapy assessment', 'timeFrame': '4 years', 'description': 'Whole body MRI with Diffusion weighted imaging is useful for treatment monitoring in multiple myeloma patients during and after therapy.\n\nMeasurement of apparent diffusion coefficient (ADC) and comparison of ADC before, during and after therapy. Correlation of ADC with clinical findings and standard MRI findings.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Whole body MRI', 'Multiple myeloma', 'Diffusion Weighted MRI', 'Whole body scan'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '22544292', 'type': 'BACKGROUND', 'citation': 'Bannas P, Hentschel HB, Bley TA, Treszl A, Eulenburg C, Derlin T, Yamamura J, Adam G, Stubig T, Kroger N, Weber C. Diagnostic performance of whole-body MRI for the detection of persistent or relapsing disease in multiple myeloma after stem cell transplantation. Eur Radiol. 2012 Sep;22(9):2007-12. doi: 10.1007/s00330-012-2445-y. Epub 2012 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'Whole body MRI with diffusion weighted imaging is a useful imaging tool\n\n* staging and diagnosis\n* therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with clinical and laboratory findings, highly suggestive for multiple myeloma. All patients underwent bone marrow biopsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical and laboratory findings, highly suggestive for multiple myeloma.\n\nExclusion Criteria:\n\n* All patients who are not allowed to be scanned on MRI (Pacemaker, implants ed.)'}, 'identificationModule': {'nctId': 'NCT01780766', 'briefTitle': 'Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI: What is the Added Value of Diffusion Weighted Imaging in Diagnosis and Follow-up', 'orgStudyIdInfo': {'id': 'FIMM'}, 'secondaryIdInfos': [{'id': 'S51079', 'type': 'OTHER', 'domain': 'Clinical Trial Centre UZ Leuven'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Indolent myeloma patient'}, {'label': 'Symptomatic Myeloma patient'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Steven Pans, MD', 'role': 'CONTACT', 'email': 'steven.pans@uzleuven.be', 'phone': '3216340505'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Steven Pans, MD', 'role': 'CONTACT', 'email': 'steven.pans@uzleuven.be', 'phone': '3216340505'}], 'overallOfficials': [{'name': 'Steven Pans, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor Radiologist', 'investigatorFullName': 'Steven Pans', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}