drugset / Trial / NCT05335811

First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging

NCT05335811 ↗

Phase 1 Recruiting 55 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelDiagnostic

Summary

18F-4FN represents a novel PET agent for imaging inflammation. Acute inflammatory signaling through the TLR axis recruits neutrophils and macrophages to inflammatory sites. Both cells activate the production of high energy reactive oxygen species/reactive nitrogen species (RONS), setting off a cascade that can be leveraged to detect the presence of these inflammatory cells by molecular imaging. 18F-4FN is efficiently oxidized by high energy RONS, leading to retention and accumulation in human neutrophil-like cells in vitro, and at the sites of acute inflammation in vivo. Like 18F-FDG, 18F-4FN clears rapidly through the kidney at 1 hr following i.v. injection

Timeline

Start
2022-10-06
Primary completion
2028-08-31
Completion
2028-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 4-[18F]Fluoro-1-Naphthol Diagnostic / imaging agent — Intravenous