TerminatedPhase 1NCT04524195

PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)

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).

Checked against the public recordLast updated Jan 17, 2024 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1
U.S. locations1
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 1
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Interventions being studied
Drug: [18F]F-AraG Injection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Johns Hopkins UniversityBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 17, 2024. Always confirm current availability with the study team.

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