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

Traumatic Injuries Clinical Trial

— PEDIMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743703
• Other study ID #: 2011-A00393-38
• Status: Completed
• Phase: N/A
• Start date: August 1, 2011
• Est. completion date: February 13, 2016

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: February 13, 2016
• Est. primary completion date: February 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Traumatic Injuries
• Wounds and Injuries

Intervention

Other:
• diagnostic whole body MRI
diagnostic whole body MRI, both STIR and diffusion weighted

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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 c — View Citation

Outcome

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