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

This study is currently recruiting participants.
Verified November 2012 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01743703
First received: November 4, 2011
Last updated: December 4, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Traumatic Injuries
 Other: diagnostic whole body MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • sensibility of MRI for detecting skeletal injuries [ Time Frame: one week ] [ Designated as safety issue: No ]
    standard skeletal imaging is used as reference

  • positive predictive value of MRI for detecting skeletal injuries [ Time Frame: one week ] [ Designated as safety issue: No ]
    standard skeletal imaging is used as reference


Secondary Outcome Measures:
  • sensibility of MRI for detecting children with skeletal injuries [ Time Frame: one week ] [ Designated as safety issue: No ]
    standard skeletal imaging is used as reference

  • specificity of MRI for detecting children with skeletal injuries [ Time Frame: one week ] [ Designated as safety issue: No ]
    standard skeletal imaging is used as reference

  • predictive positive value of MRI for detecting children with skeletal injuries [ Time Frame: one week ] [ Designated as safety issue: No ]
    standard skeletal imaging is used as reference

  • predictive negative value of MRI for detecting children with skeletal injuries [ Time Frame: one week ] [ Designated as safety issue: No ]
    standard skeletal imaging is used as reference


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
whole body MRI
diagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening)
 Other: diagnostic whole body MRI
diagnostic whole body MRI, both STIR and diffusion weighted

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743703

Contacts
Contact: Catherine Treguier, MD catherine.treguier@chu-rennes.fr

Locations
France
CHU Rennes Recruiting
Rennes, France
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Catherine Treguier, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01743703     History of Changes
Other Study ID Numbers: 2011-A00393-38
Study First Received: November 4, 2011
Last Updated: December 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
traumatic injuries
Whole-body MRI
Skeletal survey
Children
Diagnostic

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013