18F-grazy-02 PETCT Imaging to Monitor Immunotherapy Responses in Adults with Lung Cancer or Melanoma

What this Trial Is About

Researchers are evaluating 18F-grazy-02 PETCT imaging to study its safety and usefulness in monitoring immunotherapy treatments for patients with lymphoma or solid tumors, including lung cancer and melanoma. This diagnostic trial involves adults aged 18 to 75 years and focuses on immunotherapy approaches such as immune checkpoint inhibition and CAR-T cell therapy. The study is conducted in an open-label format, meaning both researchers and participants know the treatment being administered. Participants will receive an intravenous injection of 18F-grazy-02 at a dose of 2.96-3.7 MBqkg body weight. After injection, a total-body PETCT scan using a uEXPLORER scanner will be performed to image granzyme B expression. This imaging process occurs during the study period, which includes phases 1 and 2, to assess both safety and early monitoring capability of this tracer with immunotherapy. During the trial, participants will undergo PETCT imaging procedures and clinical monitoring to assess adverse events and biodistribution of 18F-grazy-02 over one year. The study also evaluates the ability of this PET tracer to monitor immunotherapy responses over a longer period of three years. Participants will be assessed for their health status, including ECOG performance score and ability to complete imaging procedures. The total study duration extends until December 2028, ensuring comprehensive safety and clinical data collection.

18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy