Study of 68Ga-JH04 PETCT to Assess Safety and Distribution in Adults with Various Solid Tumors

What this Trial Is About

Researchers are investigating the safety, biodistribution, and radiation dosimetry of 68Ga-JH04, a new radiotracer targeting fibroblast activation protein FAP, in patients with various types of cancer. FAP is a marker found on carcinoma-associated fibroblasts, which are common in many epithelial tumors but rare in normal tissues, making it a promising target for cancer diagnostics. This early phase 1 study aims to evaluate how 68Ga-JH04 behaves inside the body and its safety profile in cancer patients. Participants will receive an intravenous dose of 68Ga-JH04 ranging from 148 to 222 MBq. After injection, dynamic PET scans will be performed at multiple time points 3 minutes, 15 minutes, 30 minutes, 60 minutes, and 150 minutes. These imaging sessions will help observe how the tracer distributes and accumulates in tumors and other tissues over time. During the study, participants will undergo PETCT imaging and safety monitoring for up to one week to track any side effects or adverse reactions. Researchers will measure radiation dosimetry and biodistribution based on imaging data collected shortly after injection and up to 150 minutes later. The total duration of participation and detailed assessments are designed to ensure thorough evaluation of the tracers behavior and tolerability.

68Ga-JH04 PET/CT: Dosimetry and Biodistribution Studies