Actively Recruiting
First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
55
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient /= 18 years of age.
- Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE or patients with suspected inflammation.
- Normal range standard renal and liver function tests for age: eGFR /= 60 mL/min/1.73 m2 Adequate liver function: Bilirubin 64 the upper limit of normal (ULN) Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) 64 the ULN
You will not qualify if you...
- Pregnant or lactating women.
- 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.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that may significantly interfere with study compliance.
- Children below the age of 18.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sanjit Tewari, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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