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18F-Fluoro-1-Naphthol (18F-4FN) PET Imaging for Inflammation

This study is testing a new imaging agent called 4-[18F]Fluoro-1-Naphthol (18F-4FN) to see if it's safe and how it spreads in the body. This agent helps doctors see inflammation using a PET scan (a type of imaging that uses a special dye to show how your organs and tissues are working). The goal is to see if 18F-4FN can help identify inflammation, especially that caused by certain cancer treatments. You might be able to join if you are at least 18 years old, have a solid or liquid tumor, and are being treated with immunotherapy (ICI) with suspected inflammation, or have suspected inflammation. Your kidney and liver function must be normal. The study aims to enroll 55 participants, but its current recruitment status is unclear.

Study design
This is a first-in-human interventional study, meaning it's the first time this agent is being tested in people. It plans to enroll 55 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, looking for preliminary efficacy signals, will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05335811

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

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
M.D. Anderson Cancer Center
~55 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:4-[18F]Fluoro-1-Naphthol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To identify preliminary efficacy signals from PET images that correlate with clinical foci of ICI-related irAE.
Measured over through study completion, an average of 1 year

Conditions

Endocrine Neoplasia

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NCT05335811

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sanjit Tewari, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Sanjit Tewari, MD
[email protected]
(832) 729-1874
Email the study team

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Eligibility criteria

Inclusion

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:

Exclusion

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.

What this trial measures

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