PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)
Reason given: The study is terminated because the PI left the institution.
Key facts
- Where
- Baltimore, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Johns Hopkins UniversityBaltimore, United StatesNo longer taking part
Trial details
- Who runs it
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Trial code
- NCT04524195
- Record updated
- 17 January 2024
- Original description
This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).Read full original descriptionShow less
A Study of PET Imaging of T-cell Activation With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-directed Therapy
This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).
Inclusion: 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: 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; Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject; 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.