NCT01743703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2016

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

3.5 years

First QC Date

November 4, 2011

Last Update Submit

May 22, 2023

Conditions

Traumatic Injuries

Keywords

traumatic injuriesWhole-body MRISkeletal surveyChildrenDiagnostic

Outcome Measures

Primary Outcomes (2)

  • sensibility of MRI for detecting skeletal injuries

    standard skeletal imaging is used as reference

    one week

  • positive predictive value of MRI for detecting skeletal injuries

    standard skeletal imaging is used as reference

    one week

Secondary Outcomes (4)

  • sensibility of MRI for detecting children with skeletal injuries

    one week

  • specificity of MRI for detecting children with skeletal injuries

    one week

  • predictive positive value of MRI for detecting children with skeletal injuries

    one week

  • predictive negative value of MRI for detecting children with skeletal injuries

    one week

Study Arms (1)

whole body MRI

OTHER

diagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening)

Other: diagnostic whole body MRI

Interventions

diagnostic whole body MRIOTHER

diagnostic whole body MRI, both STIR and diffusion weighted

whole body MRI

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin

You may not qualify if:

  • Sub-dural hematoma of accidental origin or skeletal injuries of accidental
  • Origin or known origin of lesions.
  • Subject already included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

Location

Related Publications (1)

  • 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.

    PMID: 33912993RESULT

MeSH Terms

Conditions

Wounds and InjuriesDisease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Treguier, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2011

First Posted

December 6, 2012

Study Start

August 1, 2011

Primary Completion

February 13, 2015

Study Completion

February 13, 2016

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

FR(1)