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

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Enrollment increased: 55 → 65 participants
    • Eligibility criteria expanded, about 8 words
    • Study description revised
  2. 3 versions Re-verified since Apr 13, 2026, no change to tracked fieldsv14-v16
  3. Primary completion date: Dec 31, 2024 to Aug 31, 2028
    • Study completion date: Aug 31, 2026 to Aug 31, 2028
    v13
  4. Re-verified, no change to tracked fieldsv12
  5. Study completion date: Dec 31, 2024 to Aug 31, 2026
    • Site contact updated
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 30 to 55
    • Site details revised
    v10
  2. Re-verified, no change to tracked fieldsv9
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 10 to confirmed 30
    • Site details revised
    v8
  4. 3 versions Re-verified since Oct 5, 2023, no change to tracked fieldsv5-v7
  5. Eligibility criteria shortened, about 23 wordsv4
  6. Eligibility criteria shortened, about 15 wordsv3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 30, 2022 to Oct 6, 2022
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05335811
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Endocrine Neoplasia
Related terms Endocrine Gland Neoplasms
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov