ClinicalTrials.Veeva

Menu

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

C

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

Magnetic Resonance Imaging

Treatments

Other: Lung MRI examination

Study type

Interventional

Funder types

Other

Identifiers

NCT02786056
PI2014_843_0011

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Lung MRI examination
Experimental group
Treatment:
Other: Lung MRI examination

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems