Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-20 @ 11:26 AM
Study NCT ID:
NCT01743703
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2011-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2016-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2011-11-04', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensibility of MRI for detecting skeletal injuries', 'timeFrame': 'one week', 'description': 'standard skeletal imaging is used as reference'}, {'measure': 'positive predictive value of MRI for detecting skeletal injuries', 'timeFrame': 'one week', 'description': 'standard skeletal imaging is used as reference'}], 'secondaryOutcomes': [{'measure': 'sensibility of MRI for detecting children with skeletal injuries', 'timeFrame': 'one week', 'description': 'standard skeletal imaging is used as reference'}, {'measure': 'specificity of MRI for detecting children with skeletal injuries', 'timeFrame': 'one week', 'description': 'standard skeletal imaging is used as reference'}, {'measure': 'predictive positive value of MRI for detecting children with skeletal injuries', 'timeFrame': 'one week', 'description': 'standard skeletal imaging is used as reference'}, {'measure': 'predictive negative value of MRI for detecting children with skeletal injuries', 'timeFrame': 'one week', 'description': 'standard skeletal imaging is used as reference'}]}, 'conditionsModule': {'keywords': ['traumatic injuries', 'Whole-body MRI', 'Skeletal survey', 'Children', 'Diagnostic'], 'conditions': ['Traumatic Injuries']}, 'referencesModule': {'references': [{'pmid': '33912993', 'type': 'RESULT', 'citation': 'Proisy M, Vivier PH, Morel B, Bruneau B, Sembely-Taveau C, Vacheresse S, Devillers A, Lecloirec J, Bodet-Milin C, Dubois M, Hamonic S, Bajeux E, Ganivet A, Adamsbaum C, Treguier C; PEDIMA study research group. Whole-body MR imaging in suspected physical child abuse: comparison with skeletal survey and bone scintigraphy findings from the PEDIMA prospective multicentre study. Eur Radiol. 2021 Nov;31(11):8069-8080. doi: 10.1007/s00330-021-07896-9. Epub 2021 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'The diagnosis of abuse in children relies heavily on the presence of skeletal and extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And the investigators have to complete the skeletal survey with either bone-scan or CT scan or whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the evaluation of skeletal and extraskeletal lesions in children with cancer or infectious diseases. Thus, whole-body MRI would allowed to have total picture of children without ionising radiation exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin\n\nExclusion Criteria:\n\n* Sub-dural hematoma of accidental origin or skeletal injuries of accidental\n* Origin or known origin of lesions.\n* Subject already included in the study'}, 'identificationModule': {'nctId': 'NCT01743703', 'acronym': 'PEDIMA', 'briefTitle': 'Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children', 'orgStudyIdInfo': {'id': '2011-A00393-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'whole body MRI', 'description': 'diagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening)', 'interventionNames': ['Other: diagnostic whole body MRI']}], 'interventions': [{'name': 'diagnostic whole body MRI', 'type': 'OTHER', 'description': 'diagnostic whole body MRI, both STIR and diffusion weighted', 'armGroupLabels': ['whole body MRI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Catherine Treguier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}