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NCT05335811 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging
A Phase 1 study of Endocrine Neoplasia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT05335811: Recruiting Phase 1 study of Endocrine Neoplasia, sponsored by M.D. Anderson Cancer Center.
NCT05335811 is a Phase 1 study of Endocrine Neoplasia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05335811, a Phase 1 study of Endocrine Neoplasia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG 4-[18F]Fluoro-1-Naphthol
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2022-10-06 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
What NCT05335811 shows while recruiting
NCT05335811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Endocrine Neoplasia appearing as the primary indexed condition, and to 1 intervention - of which 4-[18F]Fluoro-1-Naphthol is the first listed.
NCT05335811 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05335811 about?
NCT05335811 is a clinical study titled "First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging". 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 casca...
What is the current status of trial NCT05335811?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2022-10-06. Estimated completion is 2026-08-31.
What conditions does trial NCT05335811 study?
This clinical trial studies the following conditions: Endocrine Neoplasia.
What interventions are being tested in trial NCT05335811?
The interventions under investigation include: 4-[18F]Fluoro-1-Naphthol (DRUG).
Who is sponsoring clinical trial NCT05335811?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05335811 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05335811's enrollment target sits among peer trials
55 919th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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