Recruiting
Phase 1

18F-4FN

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05335811

Conditions

Endocrine Neoplasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

4-[18F]Fluoro-1-Naphthol

Study Details

Brief 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

Conditions

Endocrine Neoplasia

Study ID

NCT05335811

Start date

Oct 6, 2022

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 ≤ 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.

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 4-[18F]Fluoro-1-Naphthol

Participants will receive 1 injection of \[18F\]4FN

Interventions

4-[18F]Fluoro-1-Naphthol

By vein (IV)

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 and Locations

Central contacts

Sanjit Tewari, MD

(832) 729-1874sotewari@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Sanjit Tewari, MD

832-729-1874sotewari@mdanderson.org

Principal Investigator:

Sanjit Tewari, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-20.