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

Summary

68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.

Timeline

Start

2024-08-01

Primary completion

2025-07-31

Completion

2025-12-31

Publications

• Zang J, Cheng H, Luo Y, Jin W, Lai Y, Zheng Q, Peng Y, Kung HF, Zhu L, Ke C, Liu C, Miao W. First-in-human study of a novel bifunctional PET tracer [68Ga]Ga-DOTA-NI-FAPI-04 targeting FAP and hypoxia. Eur J Nucl Med Mol Imaging. 2026 Mar;53(4):2530-2539. doi: 10.1007/s00259-025-07625-0. Epub 2025 Oct 31.

Drugs

Indications