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

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 20 October 2022


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



Primary Objective:

The primary objective of this first-in-human (FIH) study is to determine the safety, biodistribution, and dosimetry profile of a novel positron emission tomography (PET) imaging tracer, 4-[18F]fluoro-1-naphthol ([18F]4FN), which specifically targets reactive oxygen species (ROS). A currently proposed indication for this radiopharmaceutical (RP) is to non-invasively quantify inflammation by PET/CT imaging.

Exploratory Objectives:

One exploratory objective is to identify preliminary efficacy signals from PET/CT images indicating that the new radiopharmaceutical localized to known or clinically-suspected tissues or regions of inflammation mediated by innate immune-related adverse events (irAE). Another exploratory objective is to determine if a time point other than one-hour post injection will yield clinically meaningful improvements to imaging data.

Condition Endocrine Neoplasia
Treatment 4-[18F]Fluoro-1-Naphthol
Clinical Study IdentifierNCT05335811
SponsorM.D. Anderson Cancer Center
Last Modified on20 October 2022


Yes No Not Sure

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
</= 60 years of age or childbearing potential) within 24 hours of the PET scan
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
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