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

NCT ID: NCT01743703

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-01

Study Completion Date

2016-02-13

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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whole body MRI

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

Group Type OTHER

diagnostic whole body MRI

Intervention Type OTHER

diagnostic whole body MRI, both STIR and diffusion weighted

Interventions

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diagnostic whole body MRI

diagnostic whole body MRI, both STIR and diffusion weighted

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Treguier, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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CHU Rennes

Rennes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 33912993 (View on PubMed)

Other Identifiers

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2011-A00393-38

Identifier Type: -

Identifier Source: org_study_id

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