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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center

Criteria

Inclusion Criteria:

• Patient >/= 18 years of age.

• Subject or Legal Authorized Representative (LAR) ability and willingness to sign a written informed consent.

• Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE.

• Patients seen in the Nuclear Medicine clinic for other imaging indications where innate inflammation is suspected will be eligible for the study upon consultation with Endocrine Center physicians.

Normal range standard renal and liver function tests for age:

eGFR >= 60 mL/min/1.73 m2

Adequate liver function:

Bilirubin ≤ the upper limit of normal (ULN) Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the ULN

Exclusion Criteria:

• Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F]4FN in pregnancy are not known. Urine or serum pregnancy test (female

• Subjects with contraindications to the use of [18F]4FN including confirmed allergy.

• Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET/CT scanner, because the hardware is not intended to support that weight.

• Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance.

• Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.