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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT04250194
Eligibility Criteria:
Inclusion Criteria:
* Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:
* Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either:
* The Brock model14 if no PET scan data are available, or
* The Herder model15 if PET-CT data are available.
* Size between 10 and 30 mm (long diameter).
* Location peripheral, here defined as occupying the middle or outer third lung zones.
* Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.
Exclusion Criteria:
* Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
* Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04250194
Study Brief:
Protocol Section:
NCT04250194