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 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT01011595
Eligibility Criteria:
Inclusion Criteria:
* Lung lesion with mediastinal lymphadenopathy\* and/or positive PET scan in the mediastinum
* Lung lesion (\>1cm) without mediastinal lymphadenopathy\* or positive PET scan in the mediastinum
Exclusion Criteria:
* Age \< 18 years old
* CT or PET positivity in an extra-thoracic site (adrenal, liver, brain, bone…)
* Indeterminate pulmonary nodule less than 1cm in diameter without mediastinal lymphadenopathy\* on CT and a negative PET scan
* History of previous mediastinoscopy
* Biopsy proven positive mediastinal LN(s)
* Inability to consent for the study
* Cervical or thoracic anatomy precluding mediastinoscopy
* Inability to tolerate general anesthesia
* Pre-operative plan for carinal resection or carinal pneumonectomy (CM contraindicated prior to operative procedure due to additional difficulty secondary to scarring at time of resection)
* Active pulmonary infection (bronchitis, pneumonia)
* Active cutaneous infection overlying proposed surgical site(s)
Lymphadenopathy will be defined as short axis LN diameter of \>10 mm on CT scan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01011595
Study Brief:
Protocol Section:
NCT01011595