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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT01017133
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have a histologically confirmed NSCLC or clinical and imaging evidence of a de novo mass that is likely to be a NSCLC, stage I, II, or IIIA, for which surgery would be indicated for routine medical indications
* ECOG performance status between 0 and 2
* Subjects must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
* WBC \> 2,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Total bilirubin
* Serum AST and ALT
* Serum creatinine
* Negative serum pregnancy test if a female of childbearing age
Exclusion Criteria:
* History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5
* Uncontrolled intercurrent illness that would limit compliance with study requirements
* Pregnant women and women who are breastfeeding are excluded
* Subjects who have been treated with neoadjuvant radiation or chemotherapy prior to their biopsy or excision are excluded because the impact of these therapies upon the degree of hypoxia of the tumor is unknown
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01017133
Study Brief:
Protocol Section:
NCT01017133