Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT03553368
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03553368
Study Brief:
Protocol Section:
NCT03553368