Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children (PEDIMA)
Primary Purpose
Traumatic Injuries
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diagnostic whole body MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Injuries focused on measuring traumatic injuries, Whole-body MRI, Skeletal survey, Children, Diagnostic
Eligibility 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
Sites / Locations
- CHU Rennes
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
whole body MRI
Arm Description
diagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening)
Outcomes
Primary Outcome Measures
sensibility of MRI for detecting skeletal injuries
standard skeletal imaging is used as reference
positive predictive value of MRI for detecting skeletal injuries
standard skeletal imaging is used as reference
Secondary Outcome Measures
sensibility of MRI for detecting children with skeletal injuries
standard skeletal imaging is used as reference
specificity of MRI for detecting children with skeletal injuries
standard skeletal imaging is used as reference
predictive positive value of MRI for detecting children with skeletal injuries
standard skeletal imaging is used as reference
predictive negative value of MRI for detecting children with skeletal injuries
standard skeletal imaging is used as reference
Full Information
NCT ID
NCT01743703
First Posted
November 4, 2011
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01743703
Brief Title
Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children
Acronym
PEDIMA
Official Title
Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2011 (Actual)
Primary Completion Date
February 13, 2015 (Actual)
Study Completion Date
February 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Injuries
Keywords
traumatic injuries, Whole-body MRI, Skeletal survey, Children, Diagnostic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
whole body MRI
Arm Type
Other
Arm Description
diagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening)
Intervention Type
Other
Intervention Name(s)
diagnostic whole body MRI
Intervention Description
diagnostic whole body MRI, both STIR and diffusion weighted
Primary Outcome Measure Information:
Title
sensibility of MRI for detecting skeletal injuries
Description
standard skeletal imaging is used as reference
Time Frame
one week
Title
positive predictive value of MRI for detecting skeletal injuries
Description
standard skeletal imaging is used as reference
Time Frame
one week
Secondary Outcome Measure Information:
Title
sensibility of MRI for detecting children with skeletal injuries
Description
standard skeletal imaging is used as reference
Time Frame
one week
Title
specificity of MRI for detecting children with skeletal injuries
Description
standard skeletal imaging is used as reference
Time Frame
one week
Title
predictive positive value of MRI for detecting children with skeletal injuries
Description
standard skeletal imaging is used as reference
Time Frame
one week
Title
predictive negative value of MRI for detecting children with skeletal injuries
Description
standard skeletal imaging is used as reference
Time Frame
one week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Treguier, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33912993
Citation
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 child abuse: comparison with skeletal survey and bone scintigraphy findings from the PEDIMA prospective multicentre study. Eur Radiol. 2021 Nov;31(11):8069-8080. doi: 10.1007/s00330-021-07896-9. Epub 2021 Apr 29.
Results Reference
result
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Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children
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