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

Conditions

• Endocrine Neoplasia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 4-[18F]Fluoro-1-Naphthol — DRUG
  By vein (IV)

Study Details

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

Key Dates

Start date

Oct 6, 2022

Status verified

May 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

55 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: 4-[18F]Fluoro-1-Naphthol
  Participants will receive 1 injection of \[18F\]4FN

Primary Outcome Measure

To identify preliminary efficacy signals from PET images that correlate with clinical foci of ICI-related irAE. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

• Sanjit Tewari, MD
  (832) 729-1874
  [email protected]

Locations (1)

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