Using 68Ga-FXX489 NNS309 PETCT Scans to Detect Tumors and Metastatic Cancer A Phase 1 Study to Assess Safety and Imaging in Adults Aged 18 to 80

What this Trial Is About

Researchers are evaluating a new radiotracer called 68Ga-FXX489 NNS309 for its ability to track fibroblast activation protein FAP and visualize tumor stroma in various cancers, including pancreatic, lung, breast, gastric, and colorectal cancers. This phase 1 study aims to explore the diagnostic value, safety, imaging features, and biodistribution of 68Ga-FXX489 NNS309 PETCT imaging in oncological diseases, as well as to assess its ability to detect metastatic disease and compare it with another tracer, FAP-2286. Participants will receive an intravenous dose of 3 to 8 millicurie mCi of 68Ga-FXX489 or Gallium-68 labelled FAP-2286 before undergoing PET imaging. Imaging scans will be conducted approximately 30 to 45 minutes per session at multiple time points 30, 60, and 120 minutes after injection. Some participants may have repeat PET scans after starting treatment to evaluate changes in radiotracer uptake. The study also includes a follow-up period of up to 3 days after injection to monitor adverse events. During the trial, participants will undergo PETCT scans to assess tumor uptake, retention, and metastatic disease detection using standardized uptake values SUVs and tumor-to-background ratio TBR. Researchers will monitor safety by recording any treatment-emergent adverse events during the 3-day follow-up. The study will also evaluate radiation absorbed doses to organs and the proportion of positive lesions detected. Total participation includes imaging and safety monitoring over several days after radiotracer administration.

Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.