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

May 22, 2023 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France
        • CHU Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensibility of MRI for detecting skeletal injuries
Time Frame: one week
standard skeletal imaging is used as reference
one week
positive predictive value of MRI for detecting skeletal injuries
Time Frame: one week
standard skeletal imaging is used as reference
one week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Catherine Treguier, MD, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

February 13, 2015

Study Completion (Actual)

February 13, 2016

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00393-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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