NCT05335811 First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging
| NCT ID | NCT05335811 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Endocrine Neoplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2022-10-06 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 55 participants in total. It began in 2022-10-06 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Sanjit Tewari, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05335811 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endocrine Neoplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05335811 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05335811 currently recruiting?
Yes, NCT05335811 is actively recruiting participants. Contact the research team at sotewari@mdanderson.org for enrollment information.
Where is the NCT05335811 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05335811 clinical trial?
NCT05335811 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Sanjit Tewari, MD at M.D. Anderson Cancer Center. The trial plans to enroll 55 participants.