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Pulmonary DiseaseImagINI-CHESTNCT02714933

Thoracic MRI Imaging in Children

A study testing MRI sequence Advanced ZTE in people with Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
Pulmonary Disease
What is being tested?
MRI sequence Advanced ZTE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteFrance
Study dates
13 Feb 2017to 26 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Necker hospital

    Paris, Paris, 75015

Other trials in France

About this study

Official title: Thoracic Imaging in Children With Neither Irradiation Nor Injection, by a New MRI Protocol Including Advanced Zero Time Echo (ZTE)

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.

Read the 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.

Being tested
MRI sequence Advanced ZTE
Keywords
pulmonary, parenchyma, MRI sequence Advanced ZTE, chest computed tomography
Medical subject headings
Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI sequence Advanced ZTEOther

    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).

Study groups in NCT02714933
Study groupRoleWhat they receive
MRI sequence Advanced ZTEExperimentalNot described
Receives: Other: MRI sequence Advanced ZTE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months

Secondary outcomes (12)

  1. Noise index

    Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence

    Measured: 3 months

  2. Contrast index

    Quantitative evaluation for the quality of the image obtained by the Advanced ZTE sequence

    Measured: 3 months

  3. visual score of image quality in CT in parenchyma window in safe area

    Measured: 3 months

  4. visual score of image quality in CT in pulmonary parenchyma lesions

    Measured: 3 months

  5. visual score of image quality in MRI in parenchyma window in safe area

    Measured: 3 months

  6. visual score of image quality in MRI in pulmonary parenchyma lesions

    Measured: 3 months

  7. visual score of image quality in CT viewing the normal structures of the mediastinum

    Measured: 3 months

  8. visual score of image quality in CT viewing the mediastinal and pleural lesions or abnormalities

    Measured: 3 months

  9. visual score of image quality in MRI viewing the normal structures of the mediastinum

    Measured: 3 months

  10. visual score of image quality in MRI viewing the mediastinal and pleural lesions or abnormalities

    Measured: 3 months

  11. Number of participants with adverse events in CT

    Measured: 3 months

  12. Number of participants with adverse events in MRI

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study start13 Feb 2017
  3. Primary completion26 Aug 2019
  4. Study completion26 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02714933
Sponsor's protocol ID
P150909
Other IDs
2016-A00416-45
Acronym
ImagINI-CHEST
Status last verified
Sep 2025
First submitted
16 Mar 2016
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23701075

  • 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.

    PubMed 23830786

  • 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.

    PubMed 23213020

  • 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.

    PubMed 39066822

Questions about this trial

What is this clinical trial studying?

A study testing MRI sequence Advanced ZTE in people with Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on the Likert Scale of visual image quality (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714933, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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