ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01743703
Recruitment Status : Unknown
Verified November 2012 by Rennes University Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Traumatic Injuries Other: diagnostic whole body MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2011
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. sensibility of MRI for detecting skeletal injuries [ Time Frame: one week ]
    standard skeletal imaging is used as reference

  2. positive predictive value of MRI for detecting skeletal injuries [ Time Frame: one week ]
    standard skeletal imaging is used as reference


Secondary Outcome Measures :
  1. sensibility of MRI for detecting children with skeletal injuries [ Time Frame: one week ]
    standard skeletal imaging is used as reference

  2. specificity of MRI for detecting children with skeletal injuries [ Time Frame: one week ]
    standard skeletal imaging is used as reference

  3. predictive positive value of MRI for detecting children with skeletal injuries [ Time Frame: one week ]
    standard skeletal imaging is used as reference

  4. predictive negative value of MRI for detecting children with skeletal injuries [ Time Frame: one week ]
    standard skeletal imaging is used as reference



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01743703     History of Changes
Other Study ID Numbers: 2011-A00393-38
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: November 2012

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

Additional relevant MeSH terms:
Wounds and Injuries