Clinical Trials Directory

Trials / Completed

CompletedNCT02786056

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERLung MRI examinationLung 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.

Timeline

Start date
2015-07-01
Primary completion
2019-03-01
Completion
2019-03-01
First posted
2016-05-30
Last updated
2020-07-20

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02786056. Inclusion in this directory is not an endorsement.