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

NCT05335811 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2021-0784NCI-2022-01722
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

4-[18F]Fluoro-1-Naphthol

EXPERIMENTAL

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

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

Interventions

4-[18F]Fluoro-1-Naphthol DRUG

By vein (IV)

Also known as: [18F]4FN

4-[18F]Fluoro-1-Naphthol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Endocrine Gland Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Endocrine System Diseases

Study Officials

• Sanjit Tewari, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjit Tewari, MD

CONTACT

(832) 729-1874; sotewari@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: April 19, 2022
• Study Start: October 6, 2022
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)