Status:
TERMINATED
PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
CellSight Technologies, Inc.
Stand Up To Cancer
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 i...
Detailed Description
The purpose of this study is to find out how the radiotracer called \[18F\]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron e...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04524195
Start Date
February 1 2021
End Date
November 27 2023
Last Update
January 17 2024
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287