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

Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01743703

Acronym

PEDIMA

Enrollment

199

Registered

2012-12-06

Start date

2011-08-01

Completion date

2016-02-13

Last updated

2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Injuries

Keywords

traumatic injuries, Whole-body MRI, Skeletal survey, Children, Diagnostic

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.

Interventions

OTHERdiagnostic whole body MRI

diagnostic whole body MRI, both STIR and diffusion weighted

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
sensibility of MRI for detecting children with skeletal injuries	one week	standard skeletal imaging is used as reference
specificity 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
predictive negative value of MRI for detecting children with skeletal injuries	one week	standard skeletal imaging is used as reference

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026