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 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT04524195
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older and willing and able to provide informed consent.
* Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment.
* For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study.
Exclusion Criteria:
* Severe impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73 m2 and/or on dialysis.
* Pregnant female patients; breastfeeding female patients.
* Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
* Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
* Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04524195
Study Brief:
Protocol Section:
NCT04524195