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.
Additional locations may be listed on ClinicalTrials.gov for NCT05335811.
Locations matching your search criteria
United States
Texas
Houston
M D 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 OrganizationM D Anderson Cancer Center
Principal InvestigatorSanjit O. Tewari