This phase I trial studies the side effects of 4-[18F]fluoro-1-naphthol PET/CT for detecting inflammation in patients with cancer. Diagnostic procedures, such as 4-[18F]fluoro-1-naphthol PET/CT, may help measure a patient's response to earlier treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05335811.
Locations matching your search criteria
United States
Texas
Houston
UT MD Anderson Cancer CenterStatus: Active
Contact: Sanjit O. Tewari
Phone: 832-729-1874
PRIMARY OBJECTIVES:
I. To determine the safety, biodistribution, and dosimetry profile of a novel positron emission tomography (PET) imaging tracer, 4-[18F]fluoro-1-naphthol ([18F]4FN), which specifically targets reactive oxygen species (ROS). (Cohort A)
II. Confirmation safety monitoring for the new radiopharmaceutical. (Cohort B)
SECONDARY OBJECTIVE:
I. To document radiotracer accumulation assessed by PET in known or clinically-suspected tissues or regions of inflammation or immune-related adverse events (irAE). (Cohort B)
EXPLORATORY OBJECTIVES:
I. To identify preliminary efficacy signals from PET/computed tomography (CT) images indicating that the new radiopharmaceutical localized to known or clinically-suspected tissues or regions of inflammation mediated by innate immunity or immune-related adverse events (irAE) (Cohort B).
OUTLINE:
Patients receive 4-[18F]fluoro-1-naphthol intravenously (IV) over 1-2 minutes and undergo PET/CT on study.
After completion of study intervention, patients are followed up for 24 hours and then at 30 days.
Lead OrganizationUT MD Anderson Cancer Center
Principal InvestigatorSanjit O. Tewari