Traumatic InjuriesPEDIMANCT01743703
Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children
A study testing diagnostic whole body MRI in people with Traumatic Injuries, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Traumatic Injuries
- What is being tested?
- diagnostic whole body MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2011to 13 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin
Who cannot join
- Sub-dural hematoma of accidental origin or skeletal injuries of accidental
- Origin or known origin of lesions.
- Subject already included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children
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.
- Conditions
- Traumatic Injuries
- Being tested
- diagnostic whole body MRI
- Keywords
- traumatic injuries, Whole-body MRI, Skeletal survey, Children, Diagnostic
- Medical subject headings
- Wounds and Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic whole body MRIOther
diagnostic whole body MRI, both STIR and diffusion weighted
| Study group | Role | What they receive |
|---|---|---|
| whole body MRI | Other | diagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening) Receives: Other: diagnostic whole body MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensibility of MRI for detecting skeletal injuries
standard skeletal imaging is used as reference
Measured: one week
positive predictive value of MRI for detecting skeletal injuries
standard skeletal imaging is used as reference
Measured: one week
Secondary outcomes (4)
sensibility of MRI for detecting children with skeletal injuries
standard skeletal imaging is used as reference
Measured: one week
specificity of MRI for detecting children with skeletal injuries
standard skeletal imaging is used as reference
Measured: one week
predictive positive value of MRI for detecting children with skeletal injuries
standard skeletal imaging is used as reference
Measured: one week
predictive negative value of MRI for detecting children with skeletal injuries
standard skeletal imaging is used as reference
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study start1 Aug 2011
- Primary completion13 Feb 2015
- Study completion13 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic InjuriesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Treguier, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743703
- Sponsor's protocol ID
- 2011-A00393-38
- Acronym
- PEDIMA
- Status last verified
- May 2023
- First submitted
- 4 Nov 2011
- Last updated
- 24 May 2023
- Results posted
- No
Publications
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.
PubMed 33912993
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children
- ClinicalTrials.gov ID
- NCT01743703
- Acronym / sponsor ID
- PEDIMA / 2011-A00393-38
- Conditions
- Traumatic Injuries
- Keywords
- traumatic injuries, Whole-body MRI, Skeletal survey, Children, Diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 13 Feb 2015 (actual)
- Study completion
- 13 Feb 2016 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| whole body MRI | Other | Other: diagnostic whole body MRIdiagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening) |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin
Key exclusion criteria (3 listed)
- Sub-dural hematoma of accidental origin or skeletal injuries of accidental
- Origin or known origin of lesions.
- Subject already included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic whole body MRIdiagnostic whole body MRI, both STIR and diffusion weighted | Other | whole body MRI |
Primary outcome
sensibility of MRI for detecting skeletal injuries
Time frame: one week
standard skeletal imaging is used as reference
positive predictive value of MRI for detecting skeletal injuries
Time frame: one week
standard skeletal imaging is used as reference
4 secondary outcomes
sensibility of MRI for detecting children with skeletal injuries
Time frame: one week
specificity of MRI for detecting children with skeletal injuries
Time frame: one week
predictive positive value of MRI for detecting children with skeletal injuries
Time frame: one week
predictive negative value of MRI for detecting children with skeletal injuries
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 33912993Proisy 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.
Related trials for Traumatic Injuries
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Treguier, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic whole body MRI in people with Traumatic Injuries, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensibility of MRI for detecting skeletal injuries (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.