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Thoracic MRI Imaging in Children (ImagINI-CHEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714933
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The aim of this study is to compare a new Magnetic Resonance Imaging (MRI)protocol, including a new MRI sequence for visualization of lung parenchyma, to computed tomography as the gold standard for the evaluation of thoracic region in children.

Condition or disease Intervention/treatment Phase
Pulmonary Disease Other: MRI sequence Advanced ZTE Not Applicable

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 :

  1. MRI sequence Advanced ZTE allows visualization of normal and pathological lung parenchymal structures.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Noise index [ Time Frame: 3 months ]
    Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence

  2. Contrast index [ Time Frame: 3 months ]
    Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence

  3. visual score of image quality in CT in parenchyma window in safe area [ Time Frame: 3 months ]
  4. visual score of image quality in CT in pulmonary parenchyma lesions [ Time Frame: 3 months ]
  5. visual score of image quality in MRI in parenchyma window in safe area [ Time Frame: 3 months ]
  6. visual score of image quality in MRI in pulmonary parenchyma lesions [ Time Frame: 3 months ]
  7. visual score of image quality in CT viewing the normal structures of the mediastinum [ Time Frame: 3 months ]
  8. visual score of image quality in CT viewing the mediastinal and pleural lesions or abnormalities [ Time Frame: 3 months ]
  9. visual score of image quality in MRI viewing the normal structures of the mediastinum [ Time Frame: 3 months ]
  10. visual score of image quality in MRI viewing the mediastinal and pleural lesions or abnormalities [ Time Frame: 3 months ]
  11. Number of participants with adverse events in CT [ Time Frame: 3 months ]
  12. Number of participants with adverse events in MRI [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Locations
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France
Necker hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: laureline BERTELOOT, MD, PhD Hopital Necker, Assitance Publique-Hôpitaux de Paris
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02714933    
Other Study ID Numbers: P150909
2016-A00416-45 ( Registry Identifier: ID-RCB )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
pulmonary
parenchyma
MRI sequence Advanced ZTE
chest computed tomography
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases