Thoracic MRI Imaging in Children (ImagINI-CHEST)
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|ClinicalTrials.gov Identifier: NCT02714933|
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease||Other: MRI sequence Advanced ZTE||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thoracic Imaging in Children With Neither Irradiation Nor Injection, by a New MRI Protocol Including Advanced Zero Time Echo (ZTE)|
|Actual Study Start Date :||February 13, 2017|
|Actual Primary Completion Date :||August 26, 2019|
|Actual Study Completion Date :||August 26, 2019|
|Experimental: MRI sequence Advanced ZTE||
Other: 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).
- 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
- Noise index [ Time Frame: 3 months ]Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence
- Contrast index [ Time Frame: 3 months ]Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence
- visual score of image quality in CT in parenchyma window in safe area [ Time Frame: 3 months ]
- visual score of image quality in CT in pulmonary parenchyma lesions [ Time Frame: 3 months ]
- visual score of image quality in MRI in parenchyma window in safe area [ Time Frame: 3 months ]
- visual score of image quality in MRI in pulmonary parenchyma lesions [ Time Frame: 3 months ]
- visual score of image quality in CT viewing the normal structures of the mediastinum [ Time Frame: 3 months ]
- visual score of image quality in CT viewing the mediastinal and pleural lesions or abnormalities [ Time Frame: 3 months ]
- visual score of image quality in MRI viewing the normal structures of the mediastinum [ Time Frame: 3 months ]
- visual score of image quality in MRI viewing the mediastinal and pleural lesions or abnormalities [ Time Frame: 3 months ]
- Number of participants with adverse events in CT [ Time Frame: 3 months ]
- Number of participants with adverse events in MRI [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714933
|Paris, France, 75015|
|Principal Investigator:||laureline BERTELOOT, MD, PhD||Hopital Necker, Assitance Publique-Hôpitaux de Paris|