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Clinical Trial Summary

This early phase I trial studies how well 18F-fluoroazomycin arabinoside positron emission tomography (PET)-computed tomography (CT) works in diagnosing solid tumors. Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help to show how much oxygen is present in a tumor during a PET-CT scan.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the feasibility of PET-CT using 18F-fluoroazomycin arabinoside ([18F]FAZA) and to determine the optimal imaging time to detect hypoxia in solid tumors. SECONDARY OBJECTIVES: I. To determine the variability of imaging findings from repeated [18F]FAZA PET-CT studies over >= 24 hours up to 10 days. II. To confirm the safety of [18F]FAZA administered during PET-CT imaging of hypoxia of solid tumors. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP A: Patients receive 18F-fluoroazomycin arabinoside intravenously (IV) and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2. GROUP B: Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans >= 24 hours later up to 10 days. After completion of study treatment, patients are followed up at 24 hours and at 30 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03168737
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 22, 2017
Completion date April 30, 2025

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