Traumatic Injuries Clinical Trial
— PEDIMAOfficial title:
Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02272465 -
Prehospital Resuscitation On Helicopter Study
|
N/A | |
Enrolling by invitation |
NCT05299736 -
Human Impact Exposure Onboard High-Speed Boats
|