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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01743703
Other study ID # 2011-A00393-38
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2011
Est. completion date February 13, 2016

Study information

Verified date May 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 199
Est. completion date February 13, 2016
Est. primary completion date February 13, 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
diagnostic whole body MRI
diagnostic whole body MRI, both STIR and diffusion weighted

Locations

Country Name City State
France CHU Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & 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 c — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary sensibility of MRI for detecting skeletal injuries standard skeletal imaging is used as reference one week
Primary positive predictive value of MRI for detecting skeletal injuries standard skeletal imaging is used as reference one week
Secondary sensibility of MRI for detecting children with skeletal injuries standard skeletal imaging is used as reference one week
Secondary specificity of MRI for detecting children with skeletal injuries standard skeletal imaging is used as reference one week
Secondary predictive positive value of MRI for detecting children with skeletal injuries standard skeletal imaging is used as reference one week
Secondary predictive negative value of MRI for detecting children with skeletal injuries standard skeletal imaging is used as reference one week
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