- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02714933
Thoracic MRI Imaging in Children (ImagINI-CHEST)
Thoracic Imaging in Children With Neither Irradiation Nor Injection, by a New MRI Protocol Including Advanced Zero Time Echo (ZTE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The potential effects of ionizing radiation are of particular concern in children. Exposure to ionizing radiation of medical origin is responsible for an increased risk of brain tumors and hematopoietic lineage in children. It is therefore necessary to find alternative to the use of irradiating imaging examinations. Currently, computed tomography (CT) is the gold standard in the study of lung diseases and is used in children deepening of standard radiography in acute or chronic situations, sometimes requiring iterative controls. Chest CT delivers a radiation dose equivalent to up to 500 days of natural exposure. Moreover, for the analysis of mediastinal and vascular structures it requires an intravenous injection of iodinated contrast, potentially source of nephrotoxicity and anaphylactic reactions. Recently, new developments in Magnetic Resonance Imaging (MRI) have shown interest in the study of lung diseases when they are responsible for filling of aeric structures (mucoid impaction in cystic fibrosis, alveolar filling in infectious process and tumor) and in the analysis of vascular and mediastinal structures and heart. However, the aerated lung presenting a very low density of protons, and MRI being particularly sensitive to artifacts from cardiac and respiratory movements, sequences currently used in MRI remain insufficient in the analysis of pulmonary structures and pathologic conditions not filling aeric spaces (bronchial, cystic, emphysematous or interstitial diseases). The aim of this study is to test in clinical practice, a new MRI sequence for visualizing lung parenchyma, 3D zero Time Echo (Advanced ZTE) and to propose a protocol combining several MRI sequences without injection as an alternative to chest CT with or without contrast medium injection in childhood.
The proposed hypotheses are :
- MRI sequence Advanced ZTE allows visualization of normal and pathological lung parenchymal structures.
- A complete MRI protocol, without injection, including this sequence to those already used in clinical practice could replace the enhanced CT in most pediatric indications.
The principal objective of the study is to evaluate the Advanced ZTE sequence in the visualization of lung parenchyma structures in comparison to CT scan in lung window as gold standard.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75015
- Necker Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children, aged 6-16 years,
- Introducing one or more clinical indications for performing a chest CT with and without contrast injection within 1 day to 3 months.
- Monitoring at the Necker Hospital.
- Signature of consent by a holder of parental authority.
- Patient affiliated or beneficiary of a social security
Exclusion Criteria:
- Contraindication to performing MRI: claustrophobia, cochlear implant, nerve stimulator, pacemaker implant or intra-cardiac metallic foreign body, chest or eye.
- Need for MRI under sedation or general anesthesia.
- Indication of an emergency CT within less than 12 hours (especially suspected pulmonary embolism).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRI sequence Advanced ZTE
|
Evaluation of the image quality in terms of visualization of anatomical structures of the lung parenchyma in safe zone by a new imaging method of the pulmonary parenchyma by MRI (Advanced ZTE sequence).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score on the Likert Scale of visual image quality
Time Frame: 3 months
|
Evaluation MRI sequence Advanced ZTE in terms of image quality and visualization of the pulmonary parenchyma
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Noise index
Time Frame: 3 months
|
Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence
|
3 months
|
Contrast index
Time Frame: 3 months
|
Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence
|
3 months
|
visual score of image quality in CT in parenchyma window in safe area
Time Frame: 3 months
|
3 months
|
|
visual score of image quality in CT in pulmonary parenchyma lesions
Time Frame: 3 months
|
3 months
|
|
visual score of image quality in MRI in parenchyma window in safe area
Time Frame: 3 months
|
3 months
|
|
visual score of image quality in MRI in pulmonary parenchyma lesions
Time Frame: 3 months
|
3 months
|
|
visual score of image quality in CT viewing the normal structures of the mediastinum
Time Frame: 3 months
|
3 months
|
|
visual score of image quality in CT viewing the mediastinal and pleural lesions or abnormalities
Time Frame: 3 months
|
3 months
|
|
visual score of image quality in MRI viewing the normal structures of the mediastinum
Time Frame: 3 months
|
3 months
|
|
visual score of image quality in MRI viewing the mediastinal and pleural lesions or abnormalities
Time Frame: 3 months
|
3 months
|
|
Number of participants with adverse events in CT
Time Frame: 3 months
|
3 months
|
|
Number of participants with adverse events in MRI
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: laureline BERTELOOT, MD, PhD, Hopital Necker, Assitance Publique-Hôpitaux de Paris
Publications and helpful links
General Publications
- Gorkem SB, Coskun A, Yikilmaz A, Zurakowski D, Mulkern RV, Lee EY. Evaluation of pediatric thoracic disorders: comparison of unenhanced fast-imaging-sequence 1.5-T MRI and contrast-enhanced MDCT. AJR Am J Roentgenol. 2013 Jun;200(6):1352-7. doi: 10.2214/AJR.12.9502.
- Liszewski MC, Hersman FW, Altes TA, Ohno Y, Ciet P, Warfield SK, Lee EY. Magnetic resonance imaging of pediatric lung parenchyma, airways, vasculature, ventilation, and perfusion: state of the art. Radiol Clin North Am. 2013 Jul;51(4):555-82. doi: 10.1016/j.rcl.2013.04.004.
- Johnson KM, Fain SB, Schiebler ML, Nagle S. Optimized 3D ultrashort echo time pulmonary MRI. Magn Reson Med. 2013 Nov;70(5):1241-50. doi: 10.1002/mrm.24570. Epub 2012 Dec 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P150909
- 2016-A00416-45 (Registry Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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