Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
Study NCT ID:
NCT01374412
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2010-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D016103', 'term': 'Spinal Fractures'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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'}, {'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2010-04-14', 'studyFirstSubmitQcDate': '2011-06-15', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of microcirculation at the interface between bone and implanted xenomaterial in animal models.', 'timeFrame': 'VCT and MRI 2-6 weeks after xenomaterial implantation', 'description': 'Characteristics of the microcirculation within and in the close proximity of the bone defect in early stages and during the healing process after the placement of bone substitute materials in animal models. Correlation of functional imaging parameters derived from DCE-MRI, DWI and VCT assessed in the bone defect area with the later stage healing processes in the affected bone.'}, {'measure': 'Progression to multiple myeloma defined by SLIM-CRAB-Criteria (Rajkumar, Lancet Oncology, 2014)', 'timeFrame': 'At inclusion in the study and in repetitive follow up every 6 months until progression requiring therapy, until contraindications for MRI are present, until patient wishes to leave the study or until death (assessed up to 20 years)', 'description': 'In the study part applying functional imaging in asymptomatic myeloma patients, progression to Multiple Myeloma defined by SLIM-CRAB-Criteria is the primary outcome measure'}], 'secondaryOutcomes': [{'measure': 'Occurrence of osteolysis', 'timeFrame': 'At inclusion in the study and in repetitive follow up every 6 months until progression requiring therapy, until contraindications for MRI are present, until patient wishes to leave the study or until death (assessed up to 20 years)', 'description': 'In the study part applying functional imaging in asymptomatic myeloma patients, occurrence of osteolysis in x-ray / CT imaging is the secondary outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Multiple Myeloma', 'Vertebral Fracture']}, 'referencesModule': {'references': [{'pmid': '25439696', 'type': 'BACKGROUND', 'citation': 'Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.'}, {'pmid': '35640004', 'type': 'DERIVED', 'citation': 'Wennmann M, Klein A, Bauer F, Chmelik J, Grozinger M, Uhlenbrock C, Lochner J, Nonnenmacher T, Rotkopf LT, Sauer S, Hielscher T, Gotz M, Floca RO, Neher P, Bonekamp D, Hillengass J, Kleesiek J, Weinhold N, Weber TF, Goldschmidt H, Delorme S, Maier-Hein K, Schlemmer HP. Combining Deep Learning and Radiomics for Automated, Objective, Comprehensive Bone Marrow Characterization From Whole-Body MRI: A Multicentric Feasibility Study. Invest Radiol. 2022 Nov 1;57(11):752-763. doi: 10.1097/RLI.0000000000000891. Epub 2022 May 27.'}, {'pmid': '35608264', 'type': 'DERIVED', 'citation': 'Wennmann M, Goldschmidt H, Mosebach J, Hielscher T, Bauerle T, Komljenovic D, McCarthy PL, Merz M, Schlemmer HP, Raab MS, Sauer S, Delorme S, Hillengass J. Whole-body magnetic resonance imaging plus serological follow-up for early identification of progression in smouldering myeloma patients to prevent development of end-organ damage. Br J Haematol. 2022 Oct;199(1):65-75. doi: 10.1111/bjh.18232. Epub 2022 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and localized microcirculation in test animals with osteoporosis, fractures and after placement of bone substitute material with volume computed tomography (VCT) (animals only) and functional magnetic resonance imaging (MRI).\n\nIn vivo imaging by means of functional MRI and VCT is carried out in osteoporotic rats, both after the induction of fracture as well as after the placement of bone substitute material.\n\nFurthermore, patients with asymptomatic MM are investigated with functional MR-Imaging (Dynamic Contrast Enhancement- MRI and Intravoxel incoherent motion (IVIM)-imaging) longitudinally to predict the occurrence of osteolysis and the time to progression regarding SLIM-CRAB-Criteria (Rajkumar et al., Lancet Oncology, 2014).\n\nHypothesis:\n\n1. Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI\n2. Functional MRI has prognostic value regarding occurrence of osteolysis and progression to MM regarding SLIM-CRAB-Criteria', 'detailedDescription': 'In an experimental study, rat models were used for imaging studies employing MRI (morphological, DCE- and DWI) and VCT. Mice were not used for imaging purposes due to the small size. Rats were shown to be of optimal size for small imaging studies.\n\n144 patients with (suspected) asymptomatic MM were recruited for dynamic contrast-enhanced MRI (DCE-MRI) and diffusion weighted imaging (DWI) of the vertebral column as well as whole-body MRI using T1tse and STIR images every 6 months until progression and/ or occurrence of first osteolysis.\n\nWhile during planning and initiation of this prospective trial MM was defined by CRAB-criteria only, in 2014 the SLIM-CRAB-criteria were proposed by the International Myeloma Working Group (Rajkumar et al., Lancet Oncology, 2014) with the goal to treat patients before development of osteolysis or other CRAB-criteria. These criteria were consequently introduced in clinical practice at our institution during the observation period of this study, which affects both inclusion and progression criteria of this study. In order to obtain a conclusive cohort with homogenous inclusion and progression criteria, SLIM-CRAB-criteria where retrospectively applied to restage all patients regarding inclusion and progression to MM defined by SLIM-CRAB-criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with benign osteoporosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* benign osteoporosis\n\nExclusion Criteria:\n\n* contra-indications for MRI'}, 'identificationModule': {'nctId': 'NCT01374412', 'briefTitle': 'Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'German Cancer Research Center'}, 'officialTitle': 'Examination of Bone Defects and Microcirculation Using Volume Computed Tomography and Dynamic Contrast-enhanced Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'Transregio79B8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'osteoporosis', 'description': 'patients with benign osteoporosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'German Cancer Research Center', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Reinhard Schnettler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gießen University, Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Cancer Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heidelberg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}