First Human Study of 68Ga-NI-FAPI PETCT Imaging in Adults with Various Solid Tumors

What this Trial Is About

Researchers are evaluating a new imaging agent called 68Ga-NI-FAPI, which combines a hypoxia-sensitive nitroimidazole component with targeting of fibroblast activation protein FAP. FAP is found in most epithelial cancer-associated fibroblasts but rarely in normal tissues, making it a promising target for cancer detection. This early-phase study aims to assess the safety, distribution, radiation dose, and diagnostic usefulness of 68Ga-NI-FAPI PETCT scans in patients with various malignant tumors. Participants will receive a single intravenous injection of 68Ga-NI-FAPI at a dose of 111-148 MBq 3-4 mCi. After the injection, patients undergo PETCT imaging to visualize tumor locations and characteristics. This procedure is designed to provide detailed information about tumor presence and behavior by targeting the tumor microenvironment. The study includes only one treatment group, and the imaging is done once following the tracer administration. During the study, participants will be monitored for safety and tolerability for up to one week after the injection. Researchers will also measure the radiation exposure to normal organs and tumors from the time of injection up to 150 minutes post-injection. The total involvement includes the injection, imaging, and follow-up monitoring to evaluate how the tracer behaves in the body and its potential for cancer diagnosis.

68Ga-NI-FAPI PET/CT: First-in-human Study