Clinical trial NCT03553368: Chest Imaging of Lung Nodule(s) Under High-frequency Non-invasive Ventilation (HF-NIV)
Official title: Chest Imaging of Lung Nodule(s) Under High-frequency Non-invasive Ventilation (HF-NIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Keywords: lung nodules
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2018-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

The project was completed with an amendment to investigate MRI under continuous positive airway pressure (CPAP). The MR-CPAP combination will be evaluated with optimized parameters in healthy volunteers and compared to free-breathing acquisitions without any device.


Eligibility criteria: Inclusion Criteria:

* Validated Informed Consent as documented by signature (Appendix Informed Consent Form)
* Depending on study arm:
* Good health (step 1 and 1 bis 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)
* Any contraindication to a positive airway pressure therapy (claustrophobia, fracture of the skull, right heart failure), (step 1 bis)
* 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

Primary outcomes:
measure: Image quality, step 1: Healthy volunteers, sharpness of vessels
timeFrame: day 1
measure: Sensitivity for nodule detection, step 2: Patients (arm A)
timeFrame: day 1
measure: Sensitivity for nodule characterization, step 2: Patients (arm B)
timeFrame: day 1
measure: Assessment of CPAP-MR, step 1 bis: Healthy volunteers
timeFrame: day 1
Secondary outcomes:
measure: Image quality, step 1: Healthy volunteers, sharpness of bronchi
timeFrame: day 1
measure: Image quality, step 1: Healthy volunteers, sharpness of fissures
timeFrame: day 1
measure: Image quality, step 1: Healthy volunteers, visibility of vessels
timeFrame: day 1
measure: Image quality, step 1: Healthy volunteers, visibility of bronchi
timeFrame: day 1
measure: Image quality, step 1: Healthy volunteers, visibility of fissures
timeFrame: day 1
measure: Nodule dimensions
timeFrame: day 1
measure: MR-PET fusion
timeFrame: day 1
measure: Correlation of diffusion MRI with metabolic activity
timeFrame: day 1
measure: PET/CT stabilization assessment
timeFrame: day 1
measure: Correlation with ex-vivo nodule volume
timeFrame: day 1
measure: Tolerance CPAP-MR, step 1 bis: Healthy volunteers
timeFrame: day 1
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospitals
Study officials:
affiliation: University Hospital Lausanne (CHUV), Radiology
name: Catherine Beigelman-Aubry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beigelman-Aubry C, Peguret N, Stuber M, Delacoste J, Belmondo B, Lovis A, Simons J, Long O, Grant K, Berchier G, Rohner C, Bonanno G, Coppo S, Schwitter J, Ozsahin M, Qanadli S, Meuli R, Bourhis J. Chest-MRI under pulsatile flow ventilation: A new promising technique. PLoS One. 2017 Jun 12;12(6):e0178807. doi: 10.1371/journal.pone.0178807. eCollection 2017.
citation: Prior JO, Peguret N, Pomoni A, Pappon M, Zeverino M, Belmondo B, Lovis A, Ozsahin M, Vienne M, Bourhis J. Reduction of Respiratory Motion During PET/CT by Pulsatile-Flow Ventilation: A First Clinical Evaluation. J Nucl Med. 2016 Mar;57(3):416-9. doi: 10.2967/jnumed.115.163386. Epub 2015 Dec 3.
citation: MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.
citation: Ohno Y, Koyama H, Yoshikawa T, Seki S, Takenaka D, Yui M, Lu A, Miyazaki M, Sugimura K. Pulmonary high-resolution ultrashort TE MR imaging: Comparison with thin-section standard- and low-dose computed tomography for the assessment of pulmonary parenchyma diseases. J Magn Reson Imaging. 2016 Feb;43(2):512-32. doi: 10.1002/jmri.25008. Epub 2015 Jul 30.
citation: Darcot E, Delacoste J, Dunet V, Dournes G, Rotzinger D, Bernasconi M, Vremaroiu P, Simons J, Long O, Rohner C, Ledoux JB, Stuber M, Lovis A, Beigelman-Aubry C. Lung MRI assessment with high-frequency noninvasive ventilation at 3 T. Magn Reson Imaging. 2020 Dec;74:64-73. doi: 10.1016/j.mri.2020.09.006. Epub 2020 Sep 6.