Thoracic MRI Imaging in Children

NCT ID: NCT02714933

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2019-08-26

Brief Summary

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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

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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.

Conditions

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Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI sequence Advanced ZTE

Group Type EXPERIMENTAL

MRI sequence Advanced ZTE

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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laureline BERTELOOT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Necker, Assitance Publique-Hôpitaux de Paris

Locations

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Necker hospital

Paris, paris, France

Site Status

Countries

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France

References

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Drummond D, Marquant F, Zanelli E, Lozach C, Boddaert N, Taam RA, Neven B, Le Bourgeois M, Hadchouel A, Sarnacki S, Elie C, Delacourt C, Berteloot L. Radiation-free and injection-free imaging of the paediatric chest using a magnetic resonance imaging protocol including zero time echo sequence (3D-ZTE). Eur J Pediatr. 2024 Oct;183(10):4297-4308. doi: 10.1007/s00431-024-05678-1. Epub 2024 Jul 27.

Reference Type BACKGROUND
PMID: 39066822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23701075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23830786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23213020 (View on PubMed)

Other Identifiers

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2016-A00416-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

P150909

Identifier Type: -

Identifier Source: org_study_id

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