Study of 68GaGa-NI-FAPI-04 PETCT Imaging to Diagnose Diseases Related to Fibroblast Activation in Adults Aged 18 to 85

What this Trial Is About

Researchers are evaluating the use of 68Ga Ga-NI-FAPI-04 PETCT imaging to better understand its value in diagnosing diseases related to fibroblast activation, including tumors, cardiovascular diseases, pulmonary fibrosis, rheumatic immune diseases involving large blood vessels, hypertrophic cardiomyopathy, and other hypoxic and fibroblast-activated conditions. This study is a Phase 1 and Phase 2 clinical trial sponsored by Peking Union Medical College Hospital. Participants will receive an injection of 68Ga-NI-FAPI at a dose of 0.4-0.5 mCi per kilogram of body weight. After the injection, PETCT images will be analyzed within 30 to 120 minutes to assess the imaging agents diagnostic capabilities. The study involves only one experimental group receiving this imaging agent. During the trial, participants will undergo PETCT scans and image analysis to evaluate the diagnostic value of the imaging agent. Eligible participants include patients with tumors who can obtain pathological diagnosis through surgery or biopsy, as well as healthy volunteers without chronic diseases. The study includes monitoring for safety and follow-up over a period that meets the expected survival time of patients. The total participation duration will vary depending on individual follow-up needs but includes image analysis shortly after injection.

Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases