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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT01146366
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have proven or suspected clinical stage I NSCLC. Clinical stage IA (T1N0M0) patients are only allowed participation if the maxSUV of the primary tumor is \>/=10. Clinical stage IB (T2N0M0) must be by size criterion only (i.e. the tumor must be \> 3cm in size. Patients that have T2 tumors by visceral pleural involvement only are not eligible for the study).
2. Patients must be surgical candidates for at least a lobectomy or other anatomical resection (via either video-assisted thoracoscopic surgery, or open approach).
3. Patient must have an ECOG/Zubrod score of 0, 1 or 2.
4. Patients must not have undergone previous invasive mediastinal staging for this cancer.
5. Patients must not have a tracheostomy.
6. Patient must have a CT of the chest and upper abdomen or an FDG-PET scan performed within 60 days of enrollment to the study that confirms their clinical stage I status. Both scans must be performed, only one needs to be within 60 days of enrollment to the study.
Exclusion Criteria:
There are no separately noted exclusion criteria. All criteria are listed under inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01146366
Study Brief:
Protocol Section:
NCT01146366