Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-03-01 @ 9:11 AM
Study NCT ID:
NCT02895633
Status:
UNKNOWN
Last Update Posted:
2016-09-12
First Post:
2016-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoarticular Tumor Characterization by Advanced Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D012983', 'term': 'Soft Tissue Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1090}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-05', 'studyFirstSubmitDate': '2016-09-05', 'studyFirstSubmitQcDate': '2016-09-05', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast enhancement in echography: yes or no', 'timeFrame': 'baseline'}, {'measure': 'Contrast enhancement curve (absent, slow or fast) in echography', 'timeFrame': 'baseline'}, {'measure': 'Maximal intensity of enhancement peak in echography', 'timeFrame': 'baseline'}, {'measure': 'Mean transit time of enhancement in echography', 'timeFrame': 'baseline'}, {'measure': 'Gradient of contrast enhancement curve in echography', 'timeFrame': 'baseline'}, {'measure': 'Vascularization (dynamic analysis) in CT scanner', 'timeFrame': 'baseline', 'description': '* 0: absent\n* 1: low (\\< 20UH)\n* 2: \\> 20 UH without new blood vessels\n* 3: \\> 20 UH and/or with new blood vessels'}, {'measure': 'Contrast enhancement curve (absent, slow or fast) in CT scanner', 'timeFrame': 'baseline'}, {'measure': 'Maximal intensity of enhancement peak in CT scanner', 'timeFrame': 'baseline'}, {'measure': 'Mean transit time of enhancement in CT scanner', 'timeFrame': 'baseline'}, {'measure': 'Gradient of contrast enhancement curve in CT scanner', 'timeFrame': 'baseline'}, {'measure': 'Contrast enhancement curve (absent, slow or fast) in MRI', 'timeFrame': 'baseline'}, {'measure': 'Maximal intensity of enhancement peak in MRI', 'timeFrame': 'baseline'}, {'measure': 'Mean transit time of enhancement in MRI', 'timeFrame': 'baseline'}, {'measure': 'Gradient of contrast enhancement curve in MRI', 'timeFrame': 'baseline'}, {'measure': 'Choline peak in magnetic resonance spectroscopy', 'timeFrame': 'baseline', 'description': 'Choline presence was defined as a clear metabolite peak at 3.2 ppm'}, {'measure': 'Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging', 'timeFrame': 'baseline', 'description': 'ADC value in mm2/s'}, {'measure': 'Area under the perfusion curve in MRI', 'timeFrame': 'baseline'}, {'measure': 'Perfusion curve gradient in MRI', 'timeFrame': 'baseline'}, {'measure': 'Perfusion time-to-peak in MRI', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MR imaging', 'Diffusion weighted imaging', 'MR proton spectroscopy', 'CT perfusion', 'Contrast enhanced ultrasound'], 'conditions': ['Bone Tumor', 'Soft Tissue Tumor']}, 'referencesModule': {'references': [{'pmid': '33765161', 'type': 'DERIVED', 'citation': 'Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to compare and evaluate multiple functional imaging methods (perfusion, diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular tumors and to determine which method or which association of methods could improve non invasive tissue characterization.\n\nSecondary purposes are:\n\n* to determine a possible correlation between some parameters and the histological grade (FNCLCC)\n* to suggest a coherent diagnostic imaging approach for osteoarticular tumors.\n\nThe ancillary study will enroll patients needing radiological tumor follow-up. The purpose is to identify tools for evaluation of tumor activity and therapeutic response before modification of morpho-volumetric data.', 'detailedDescription': 'Patients refered for the initial evaluation of suspected osteoarticular masses will be included in this study after signing an informed consent.\n\nHistologic analysis will be used as a gold standard.\n\nThe following imaging techniques will be evaluated:\n\n* contrast enhanced ultrasonography\n* Low dose CT perfusion\n* Magnetic resonance perfusion\n* Diffusion weighted imaging\n* Magnetic resonance proton spectroscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients examined for initial assessment of bone or peripheral soft-tissue primitive tumor\n* patients with normal awareness level\n* patients having signed informed consent\n\nExclusion Criteria:\n\n* pregnant women\n* persons deprived of liberty\n* persons under legal protection or unable to give informed consent\n* persons in life-threatening emergency\n* allergy to Sonovue, iodinated contrast media or gadolinium chelates\n* risk of pregnancy\n* breastfeeding women\n* acute coronary syndrome or unstable ischemic cardiopathy (ban on injection of contrast agent for CT scan)\n* renal failure (ban on injection of contrast agent for MRI and CT scan)\n* contraindication to MRI'}, 'identificationModule': {'nctId': 'NCT02895633', 'acronym': 'TUMOSTEO', 'briefTitle': 'Osteoarticular Tumor Characterization by Advanced Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Osteoarticular Tumor Characterization by Advanced Imaging', 'orgStudyIdInfo': {'id': '2009-A00758-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with bone or peripheral soft-tissue tumor', 'interventionNames': ['Other: Ecography', 'Other: CT scan', 'Other: MRI']}], 'interventions': [{'name': 'Ecography', 'type': 'OTHER', 'description': 'Standard Doppler ultrasound and perfusion imaging after injection of Sonovue', 'armGroupLabels': ['Patients with bone or peripheral soft-tissue tumor']}, {'name': 'CT scan', 'type': 'OTHER', 'description': 'With injection of Iomeron 400', 'armGroupLabels': ['Patients with bone or peripheral soft-tissue tumor']}, {'name': 'MRI', 'type': 'OTHER', 'description': 'With injection of gadolinium (Multihance)', 'armGroupLabels': ['Patients with bone or peripheral soft-tissue tumor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'facility': "Service d'Imagerie Guilloz, CHRU Nancy", 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Pedro Augusto GONDIM TEIXEIRA', 'role': 'CONTACT', 'email': 'ped_gt@hotmail.com'}], 'overallOfficials': [{'name': 'Pedro Augusto GONDIM TEIXEIRA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Imagerie Guilloz, CHRU Nancy"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}