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Thoracic MRI Imaging in Children (ImagINI-CHEST)

Primary Purpose

Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI sequence Advanced ZTE
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Disease focused on measuring pulmonary, parenchyma, MRI sequence Advanced ZTE, chest computed tomography

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Necker hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI sequence Advanced ZTE

Arm Description

Outcomes

Primary Outcome Measures

Score on the Likert Scale of visual image quality
Evaluation MRI sequence Advanced ZTE in terms of image quality and visualization of the pulmonary parenchyma

Secondary Outcome Measures

Noise index
Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence
Contrast index
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
visual score of image quality in CT in pulmonary parenchyma lesions
visual score of image quality in MRI in parenchyma window in safe area
visual score of image quality in MRI in pulmonary parenchyma lesions
visual score of image quality in CT viewing the normal structures of the mediastinum
visual score of image quality in CT viewing the mediastinal and pleural lesions or abnormalities
visual score of image quality in MRI viewing the normal structures of the mediastinum
visual score of image quality in MRI viewing the mediastinal and pleural lesions or abnormalities
Number of participants with adverse events in CT
Number of participants with adverse events in MRI

Full Information

First Posted
March 16, 2016
Last Updated
October 3, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02714933
Brief Title
Thoracic MRI Imaging in Children
Acronym
ImagINI-CHEST
Official Title
Thoracic Imaging in Children With Neither Irradiation Nor Injection, by a New MRI Protocol Including Advanced Zero Time Echo (ZTE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
Keywords
pulmonary, parenchyma, MRI sequence Advanced ZTE, chest computed tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI sequence Advanced ZTE
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MRI sequence Advanced ZTE
Intervention Description
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 Measure Information:
Title
Score on the Likert Scale of visual image quality
Description
Evaluation MRI sequence Advanced ZTE in terms of image quality and visualization of the pulmonary parenchyma
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Noise index
Description
Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence
Time Frame
3 months
Title
Contrast index
Description
Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence
Time Frame
3 months
Title
visual score of image quality in CT in parenchyma window in safe area
Time Frame
3 months
Title
visual score of image quality in CT in pulmonary parenchyma lesions
Time Frame
3 months
Title
visual score of image quality in MRI in parenchyma window in safe area
Time Frame
3 months
Title
visual score of image quality in MRI in pulmonary parenchyma lesions
Time Frame
3 months
Title
visual score of image quality in CT viewing the normal structures of the mediastinum
Time Frame
3 months
Title
visual score of image quality in CT viewing the mediastinal and pleural lesions or abnormalities
Time Frame
3 months
Title
visual score of image quality in MRI viewing the normal structures of the mediastinum
Time Frame
3 months
Title
visual score of image quality in MRI viewing the mediastinal and pleural lesions or abnormalities
Time Frame
3 months
Title
Number of participants with adverse events in CT
Time Frame
3 months
Title
Number of participants with adverse events in MRI
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
laureline BERTELOOT, MD, PhD
Organizational Affiliation
Hopital Necker, Assitance Publique-Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker hospital
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23701075
Citation
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.
Results Reference
background
PubMed Identifier
23830786
Citation
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.
Results Reference
background
PubMed Identifier
23213020
Citation
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.
Results Reference
background

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Thoracic MRI Imaging in Children

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