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

NCT03553368 | Completed

• 1 other identifier: HF-NIV-MR-PET
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

lung nodules

Outcome Measures

Primary Outcomes (4)

• Image quality, step 1: Healthy volunteers, sharpness of vessels

  Sharpness of interfaces of vessels will be scored on a discrete scale as 1=blurred; 2=intermediate; 3=sharp. This will determine the adequate choice of MR sequences and parameters.

  day 1

• Sensitivity for nodule detection, step 2: Patients (arm A)

  Determine whether HF-NIV-MR allows a better detection (higher sensitivity) of the presence of pulmonary nodules compared with conventional MR. CT will be used as gold standard.

  day 1

• Sensitivity for nodule characterization, step 2: Patients (arm B)

  Determine whether sensitivity of the apparent diffusion coefficient (ADC) value obtained with HF-NIV-MR (diffusion sequence) to characterize nodules is higher than the sensitivity obtained with conventional MRI. Histological data will be used as gold standard when available.

  day 1

• Assessment of CPAP-MR, step 1 bis: Healthy volunteers

  Determine whether CPAP-MR has an additional value compared with MR. Image quality of the CPAP-MR acquisition will be evaluated similarly to the methodology of step 1 and compared to the gold standard MR acquisition (free-breathing without any device).

  day 1

Secondary Outcomes (11)

• Image quality, step 1: Healthy volunteers, sharpness of bronchi

  day 1

• Image quality, step 1: Healthy volunteers, sharpness of fissures

  day 1

• Image quality, step 1: Healthy volunteers, visibility of vessels

  day 1

• Image quality, step 1: Healthy volunteers, visibility of bronchi

  day 1

• Image quality, step 1: Healthy volunteers, visibility of fissures

  day 1

Study Arms (4)

Step 1: Healthy volunteers

EXPERIMENTAL

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).

Diagnostic Test: HF-NIV-MR; Diagnostic Test: MR

Step 2: Patients (arm A)

EXPERIMENTAL

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.

Diagnostic Test: HF-NIV-MR; Diagnostic Test: MR

Step 2: Patients (arm B)

EXPERIMENTAL

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.

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

Step 1 bis: Healthy volunteers

EXPERIMENTAL

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).

Diagnostic Test: MR; Diagnostic Test: CPAP-MR

Interventions

HF-NIV-MR DIAGNOSTIC_TEST

MRI data will be acquired with the use of HF-NIV.

Step 1: Healthy volunteers; Step 2: Patients (arm A); Step 2: Patients (arm B)

HF-NIV-PET DIAGNOSTIC_TEST

PET data will be acquired with the use of HF-NIV.

Step 2: Patients (arm B)

MR DIAGNOSTIC_TEST

MRI data will be acquired without the use of any device as a reference.

Step 1 bis: Healthy volunteers; Step 1: Healthy volunteers; Step 2: Patients (arm A); Step 2: Patients (arm B)

PET/CT breath hold DIAGNOSTIC_TEST

PET/CT data will be acquired in inspiratory breath hold without the use of HF-NIV.

Step 2: Patients (arm B)

CPAP-MR DIAGNOSTIC_TEST

MRI data will be acquired with the use of CPAP.

Step 1 bis: Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

University Hospitals

Lausanne, 1011, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 28604833 BACKGROUND

• 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.

  PMID: 26635339 BACKGROUND

• 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.

  PMID: 28240562 BACKGROUND

• 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.

  PMID: 26223818 BACKGROUND

• 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.

  PMID: 32898653 RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Catherine Beigelman-Aubry, MD

  University Hospital Lausanne (CHUV), Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD-MER, Head of the Chest Imaging Unit

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 12, 2018
• Study Start: June 14, 2018
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)