Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children

Not Applicable

Completed

• Conditions: Traumatic Injuries
• Interventions: Other: diagnostic whole body MRI

• Registration Number: NCT01743703
• Lead Sponsor: Rennes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-01
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Primary Completion: 2015-02-13
• Study Completion: 2016-02-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin

Exclusion Criteria

• Sub-dural hematoma of accidental origin or skeletal injuries of accidental
• Origin or known origin of lesions.
• Subject already included in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
whole body MRI	diagnostic whole body MRI	diagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening)

Primary Outcome Measures

Name	Time	Method
sensibility of MRI for detecting skeletal injuries	one week	standard skeletal imaging is used as reference
positive predictive value of MRI for detecting skeletal injuries	one week	standard skeletal imaging is used as reference

Secondary Outcome Measures

Name	Time	Method
specificity of MRI for detecting children with skeletal injuries	one week	standard skeletal imaging is used as reference
sensibility of MRI for detecting children with skeletal injuries	one week	standard skeletal imaging is used as reference
predictive negative value of MRI for detecting children with skeletal injuries	one week	standard skeletal imaging is used as reference
predictive positive value of MRI for detecting children with skeletal injuries	one week	standard skeletal imaging is used as reference

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France