Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Chest Imaging of Lung Nodule(s) Under High-frequency Non-invasive Ventilation (HF-NIV)

Summary: Imaging of chest disorders is mainly achieved by using computed tomography. This is especially the case for detection, morphologic assessment and followup of pulmonary nodules. A positron emission tomography (PET) /CT may be additionally required for lung nodule management in some conditions including a size greater than 8 mm with morphologic or growing characteristics suspicious of malignancy. Magnetic Resonance Imaging (MRI) represents however an interesting alternative diagnostic radiation-free method, in particular owing to the recent development of sequences dedicated to lung parenchyma analysis. A major limitation remains the control of respiratory artefacts.
  High Frequency non-invasive ventilation, HF-NIV, has the potential to allow chest stabilization and is currently used in the department of radio-oncology at the Lausanne University Hospital. It has been recently applied to perform MRI and PET examinations at end inspiration during an "apnea " generated by the system. Continuous periods of respiratory stabilization of several minutes at end-inspiration are thus obtained, allowing prolonged MR and PET acquisitions with improvement of image quality as observed in our preliminary studies (Beigelman-Aubry et al., Prior et al.). Interestingly, the lung volume explored by using this ventilation technique is similar to that of CT studies, conversely to respiratory gated MR sequences which are currently performed at end-expiration, this potentially generating underevaluation of lung disorders especially at lung bases.
  The present project aims to determine the impact of HF-NIV in the management of patients with pulmonary nodule(s). After a first step of optimization of acquisition parameters of HF-NIV-MR in healthy volunteers, the performances of MRI and PET/CT (when required) under this ventilation technique will be compared to the current method(s) of reference in cases of pulmonary nodule(s) (CT scan and PET when required) and histological data when available. All MRI and PET/CT (when required) acquisitions will be performed without the ventilation technique, as used in current practice, and with it.


Eligibility: Inclusion Criteria:
  -  Validated Informed Consent as documented by signature (Appendix Informed Consent Form)
  -  Depending on study arm:
  -  Good health (step 1 only) or
  -  Patients with at least 1 non calcified pulmonary nodule of at least 4 mm, whatever its texture (solid, sub-solid) and nature (benign, indeterminate or malignant), just discovered or in a follow-up context (step 2 only)
  -  Age ≥ 18 years
  Exclusion Criteria:
  -  Previous or current disorder that might interfere with performance or safety of study procedures
  -  Age <18 years
  -  Any contraindication to MRI (pace makers, neuro-stimulators, some implantable devices, some metallic implants, claustrophobia)
  -  Children, adolescents and adults with incapacities
  -  Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  -  Pregnant or breastfeeding women
  -  Chronic obstructive pulmonary disease (COPD) or asthma with severe obstruction
  -  Severe obstructive patients (FEV1<50% of predicted value)
  -  Hypoxemia (SaO2<94% AA)
  -  History or physical signs of right heart failure
  -  History or physical signs of right or left cardiac failure
  -  History or physical signs of pulmonary hypertension
  -  History or physical signs of active coronary artery disease
  -  Pulmonary graft
  -  Immunocompromized patients
  -  Enrollment of the investigator, his/her family members, employees and other dependent persons

Relevance to patient case: not relevant