NCT02714933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

March 16, 2016

Last Update Submit

September 5, 2025

Conditions

Pulmonary Disease

Keywords

pulmonaryparenchymaMRI sequence Advanced ZTEchest computed tomography

Outcome Measures

Primary Outcomes (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

    3 months

Secondary Outcomes (12)

  • Noise index

    3 months

  • Contrast index

    3 months

  • visual score of image quality in CT in parenchyma window in safe area

    3 months

  • visual score of image quality in CT in pulmonary parenchyma lesions

    3 months

  • visual score of image quality in MRI in parenchyma window in safe area

    3 months

  • +7 more secondary outcomes

Study Arms (1)

MRI sequence Advanced ZTE

EXPERIMENTAL
Other: MRI sequence Advanced ZTE

Interventions

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).

MRI sequence Advanced ZTE

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker hospital

Paris, paris, 75015, France

Location

Related Publications (4)

  • 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.

    PMID: 39066822BACKGROUND

  • 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.

    PMID: 23701075BACKGROUND

  • 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.

    PMID: 23830786BACKGROUND

  • 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.

    PMID: 23213020BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • laureline BERTELOOT, MD, PhD

    Hopital Necker, Assitance Publique-Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 22, 2016

Study Start

February 13, 2017

Primary Completion

August 26, 2019

Study Completion

August 26, 2019

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)