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Completed

NCT Number: NCT02786056

Feasibility of Regional Lung Ventilation Imaging Using 3T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences

Structural lung and airway alterations in CF lead to focal or heterogeneous abnormalities in regional lung ventilation. The quantitative assessment of structural and functional alterations in the lung is of great importance for the phenotyping and follow-up of CF patients. The goal of this study is to assess the feasibility of measuring the changes in proton density in the lung parenchyma with inflation and deflation during the respiratory cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

About this study

Cystic fibrosis (CF) is the most common severe autosomal recessive genetic disease in Caucasians. severe structural alterations in the airways and parenchyma, such as bronchiectasis, mucus plugging, air trapping and infiltrations. These in turn result in focal or heterogeneous abnormalities in regional lung ventilation. End-stage lung disease remains the main cause of morbidity and mortality in CF patients. Currently, new targeted CFTR correctors and potentiators are under trial. The quantitative assessment of structural and functional alterations in the lung is of great importance for the phenotyping and follow-up of CF patients, and for the assessment of targeted therapeutic interventions. Computed tomography (CT) is considered as the technology of choice for lung imaging in CF. However, CT requires exposure to significant ionizing radiation, which is a major concern in the pediatric population because children are more radiosensitive than adults and there is an increased risk of radiation-induced cancer from the cumulative dose related to repeated CT investigations. Recent improvements in magnetic resonance imaging (MRI) technology offer a non-ionizing alternative to CT for imaging the lung parenchyma. The goal of this study is to assess the feasibility of measuring the changes in proton density in the lung parenchyma with inflation and deflation during the respiratory cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers. If the regional changes in proton density in the lung parenchyma during the respiratory cycle prove to be measurable in healthy volunteers, then MRI can be used to quantify regional lung ventilation. This would offer a unique non-invasive, radiation- and contrast media-free alternative to CT for phenotyping and follow-up of CF patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subject aged 18 to 65 years.
  • Written informed consent.
  • Health insurance policy holder.

Exclusion criteria

  • Current smoker
  • Detained or legally irresponsable.
  • No social security or health insurance policy.
  • Chronic respiratory diseases (such as asthma, COPD, CF, pulmonary fibrosis or hypertension).
  • Acute or recent lower respiratory tract infection.
  • Smoking or heavy meal less than 1 hour prior to imaging.
  • Acute or recent serious health condition (such as : myocardial infarction, pulmonary embolism…).
  • MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, metallic ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.

Treatment and study plan

Lung MRI examination

Other

Lung MRI examination is performed for approximately 30 min on a 3T machine (Achieva 3T, Philips) using UTE sequences, both during free breathing with image synchronisation using an echo-navigator, and during an end-inspiratory and end-expiratory pauses. In the 10 first subjects, the MR protocol is optimized in order to maximize MRI parenchymal signal intensity, signal-to-noise ratio and contrast-to-noise ratio. The final image acquisition parameters will be applied in the following 30 subjects in order to assess the outcomes of the study.

Primary outcomes

  1. Correlation between the magnitude of change in MRI signal intensity from end-inspiration to end-expiration, averaged over the entire 3D lung image, and tidal volume measured by spirometry during imaging

    Time frame: 30 days

Secondary outcomes

  1. Agreement between the correlation coefficient of MRI signal intensity change vs. tidal volume acquired during free breathing, and that acquired in static conditions (end-inspiration, end-expiration)

    Time frame: 30 days

  2. Comparison of signal-to-noise and contrast-to-noise ratio of lung parenchyma measured using UTE MRI to values published in the litterature.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Feasibility of Regional Lung Ventilation Imaging Using 3T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences (PULMOREM Study)

Acronym: PULMOREM

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 30, 2016
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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