drugset / Trial / NCT05121779

Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT

NCT05121779

Phase 1 Recruiting 80 enrolled Peking Union Medical College Hospital
NaSingle-groupOpen-labelDiagnostic

Summary

68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of Pulmonary fibrosis than 18F-FDG PET/CT.

Timeline

Start
2021-11-18
Primary completion
2025-12-01
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-FDG Diagnostic / imaging agent 4.44 mbq/kg Intravenous
Subject 18F-FDG Diagnostic / imaging agent 5.55 mbq/kg Intravenous
Subject FAPI GA-68 Diagnostic / imaging agent 18.5 mbq/kg Intravenous
Subject FAPI GA-68 Diagnostic / imaging agent 22.2 mbq/kg Intravenous

Indications