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

Launched by M.D. ANDERSON CANCER CENTER · Apr 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging agent called 18F-Fluoro-1-Naphthol (18F-4FN) designed to help doctors see inflammation in the body using a special type of scan called PET imaging. The trial aims to assess the safety of this agent and how it spreads in the body after being injected. It’s particularly focused on patients with certain types of tumors who may be experiencing inflammation due to their treatment.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of a solid or liquid tumor. They should also have normal kidney and liver function. Pregnant or breastfeeding women are not allowed to join the study, nor are those with certain allergies or medical conditions that could interfere with the results. If you participate, you can expect to receive the injection of 18F-4FN, followed by a PET scan to see how well it works in highlighting areas of inflammation. This trial is currently recruiting participants, and it’s a great opportunity to contribute to research that may help improve imaging for patients with inflammation related to tumors.

Gender

ALL

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.