- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01743703
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
-
-
-
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)
|
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
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.
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
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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