Clinical trial · Interventional
Chest Imaging of Lung Nodule(s) Under High-frequency Non-invasive Ventilation (HF-NIV)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPAP-MR | Diagnostic Test | — | UNRESOLVED |
| HF-NIV-MR | Diagnostic Test | — | UNRESOLVED |
| HF-NIV-PET | Diagnostic Test | — | UNRESOLVED |
| MR | Diagnostic Test | — | UNRESOLVED |
| PET/CT breath hold | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Step 1: Healthy volunteers
- 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).
- interventionNames
- Diagnostic Test: HF-NIV-MR
- Diagnostic Test: MR
- type
- EXPERIMENTAL
- label
- Step 2: Patients (arm A)
- 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.
- interventionNames
- Diagnostic Test: HF-NIV-MR
- Diagnostic Test: MR
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDBeigelman-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
- BACKGROUNDPrior 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
- BACKGROUNDMacMahon 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
- BACKGROUNDOhno 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
- RESULTDarcot 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