Supplementation of Skeletal Survey with Whole Body MRI for Fracture Detection in Children with Suspected Physical Abuse
C
Christopher Newman
Primary Investigator
Enrolling By Invitation
2 years or below
All
Phase
N/A
100 participants needed
1 Location
Brief description of study
What is the purpose of this study?
Children with a skeletal survey for suspected physical abuse who are already receiving MR imaging for possible neurological injuries will be imaged with additional whole body MRI. They will also receive a clinical follow up skeletal survey, which will serve as the reference standard for the study.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants will be identified by dedicated research coordinators, ordering providers, subspecialty consultants, and radiology technologists after an order has been placed for a radiographic skeletal survey in a child under two years old with clinical concern for nonaccidental trauma. These patients will be incorporated into the routine coordinator workflow, which will be supplemented by Electronic Medical Record Alerts for patients fulfilling the inclusion criteria. After notification, a research coordinator or subspecialty consultant will approach the consenting caregiver. Subjects may be present through emergency department, through outpatient clinics after an incidental concern has arisen, or through direct admission when concern has arisen from an outside institution. Consent will be obtained at Riley Hospital for Children by a clinical research coordinator or subspecialty consultant from the child’s legal surrogate.
Detailed description of study
What will happen during the study?
This study is a paired single center prospective study of whole body MR imaging in children under two years old who have received skeletal surveys for suspected physical abuse and will receive MR imaging for possible neurological injuries. A whole body 3D STIR sequence will be added to the routine brain and spine MR sequences obtained in these subjects. Approximately two weeks later (as per clinical protocol), a follow up skeletal survey will be obtained.
Initial skeletal surveys will be evaluated by a consensus review conducted by two pediatric radiologists blinded to the results of the whole body MRI images. Whole body MR images will subsequently be evaluated using a consensus review by the same two pediatric radiologists, who will also have access to the initial skeletal survey. The follow up skeletal survey, which will serve as the reference standard, will be evaluated by a consensus review conducted by two different pediatric radiologists blinded to the initial skeletal survey and whole body MRI.
For initial skeletal surveys and whole body MRI, a positive study is defined as the presence of fractures or findings equivocal for fractures, whereas a negative study is defined as the absence of fractures or equivocal findings. For the reference standard, a positive study is defined as the presence of fractures, whereas a negative study is defined by the absence of fractures. Image interpretation will occur throughout accrual rather than being batched at the end of the study. Once all exams have been interpreted, sensitivity will be calculated for the combination of whole body MRI and the initial skeletal survey as well as for the initial skeletal survey alone.
Initial skeletal surveys will be evaluated by a consensus review conducted by two pediatric radiologists blinded to the results of the whole body MRI images. Whole body MR images will subsequently be evaluated using a consensus review by the same two pediatric radiologists, who will also have access to the initial skeletal survey. The follow up skeletal survey, which will serve as the reference standard, will be evaluated by a consensus review conducted by two different pediatric radiologists blinded to the initial skeletal survey and whole body MRI.
For initial skeletal surveys and whole body MRI, a positive study is defined as the presence of fractures or findings equivocal for fractures, whereas a negative study is defined as the absence of fractures or equivocal findings. For the reference standard, a positive study is defined as the presence of fractures, whereas a negative study is defined by the absence of fractures. Image interpretation will occur throughout accrual rather than being batched at the end of the study. Once all exams have been interpreted, sensitivity will be calculated for the combination of whole body MRI and the initial skeletal survey as well as for the initial skeletal survey alone.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Brain Injury, Bone Injury, Skeletal injury
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Age: 2 years or below
-
Gender: All
Inclusion Criteria
1. Less than two years old.
2. Received a skeletal survey for the initial evaluation of suspected physical abuse.
3. Clinical concern for abusive neurological injuries warranting MR brain and spine imaging.
Exclusion Criteria
1. Contraindications to MR imaging.
2. Contraindications for sedation or general anesthesia for subjects unable to complete the MR examination without sedation or general anesthesia.
3. Accidental trauma with a mechanism of injury consistent with clinical and radiological findings.
1. Less than two years old.
2. Received a skeletal survey for the initial evaluation of suspected physical abuse.
3. Clinical concern for abusive neurological injuries warranting MR brain and spine imaging.
Exclusion Criteria
1. Contraindications to MR imaging.
2. Contraindications for sedation or general anesthesia for subjects unable to complete the MR examination without sedation or general anesthesia.
3. Accidental trauma with a mechanism of injury consistent with clinical and radiological findings.
Updated on
28 May 2025.
Study ID: RADY-IIR-23552, 23552
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