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

Lausanne University Hospital (CHUV)

Status: Completed

Conditions: Neoplasms

Treatments: Diagnostic Test: HF-NIV-MR; Diagnostic Test: CPAP-MR; Diagnostic Test: PET/CT breath hold; Diagnostic Test: HF-NIV-PET; Diagnostic Test: MR

Study type: Interventional

Funder types: Other

Identifiers

NCT03553368

HF-NIV-MR-PET

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Step 1: Healthy volunteers

Experimental group

Description:

Experimental intervention: MRI data will be acquired with the use of HF-NIV (HF-NIV-MR). Control intervention: MRI data will be acquired without the use of HF-NIV, as a reference (MR).

Treatment:

Diagnostic Test: MR

Diagnostic Test: HF-NIV-MR

Step 2: Patients (arm A)

Experimental group

Description:

Experimental intervention: MRI data will be acquired with the use of HF-NIV (HF-NIV-MR). Control intervention: MRI data will also be acquired without the use of HF-NIV, as a reference (MR). The clinically prescribed CT will be the gold standard.

Treatment:

Diagnostic Test: MR

Diagnostic Test: HF-NIV-MR

Step 2: Patients (arm B)

Experimental group

Description:

Experimental intervention: PET/CT data will be acquired with the use of HF-NIV (HF-NIV-PET). MRI data will be acquired with the use of HF-NIV (HF-NIV-MR). PET/CT data will be acquired in inspiratory breath hold without the use of HF-NIV (PET/CT breath hold). Control intervention: Data from the clinically indicated PET/CT acquisition will be used as reference. MRI data will also be acquired without the use of HF-NIV, as a reference (MR). Histological data will be used when available.

Treatment:

Diagnostic Test: MR

Diagnostic Test: HF-NIV-MR

Diagnostic Test: PET/CT breath hold

Diagnostic Test: HF-NIV-PET

Step 1 bis: Healthy volunteers

Experimental group

Description:

Experimental intervention: MRI data will be acquired with the use of CPAP (CPAP-MR). Control intervention: MRI data will be acquired without the use of CPAP, as a reference (MR).

Treatment:

Diagnostic Test: MR

Diagnostic Test: CPAP-MR