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临床试验/NCT03553368
NCT03553368已完成不适用

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

University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Assessment of CPAP-MR, step 1 bis: Healthy volunteers

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: day 1

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).

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

时间窗: day 1

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.

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

时间窗: day 1

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.

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

时间窗: day 1

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.

次要结局

  • Image quality, step 1: Healthy volunteers, sharpness of bronchi(day 1)
  • Image quality, step 1: Healthy volunteers, visibility of vessels(day 1)
  • Correlation of diffusion MRI with metabolic activity(day 1)
  • Tolerance CPAP-MR, step 1 bis: Healthy volunteers(day 1)
  • Image quality, step 1: Healthy volunteers, visibility of bronchi(day 1)
  • Image quality, step 1: Healthy volunteers, visibility of fissures(day 1)
  • Image quality, step 1: Healthy volunteers, sharpness of fissures(day 1)
  • Nodule dimensions(day 1)
  • MR-PET fusion(day 1)
  • PET/CT stabilization assessment(day 1)
  • Correlation with ex-vivo nodule volume(day 1)

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beigelman-Aubry Catherine

PD-MER, Head of the Chest Imaging Unit

University of Lausanne Hospitals

研究点 (2)

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