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Fluorides

Fluoroazomycin arabinoside

Radiopharmaceuticals

Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2.

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.

Computed Tomography

Fluorine F 18-fluoroazomycin Arabinoside

Positron Emission Tomography

Franklin C Wong

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.

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.

18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients

Test-Retest of (18)F-Fluoroazomycin Arabinoside ([18F]FAZA) PET-CT of Solid Tumors

Summary statistics of tumor volume, SUV, TMR, HTV1, HTV2, TLH1, TLH2, and their changes from baseline to later time point will be provided in mean, standard deviation, and range by time point. Lin's concordance correlation coefficient for these parameters will be calculated and MDC95 will also be calculated for 2 hour timepoint or other time points. Other statistical analyses will be carried out as appropriate.

Adverse events and vital signs will be monitored and described with descriptive statistics.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients	NCT03168737	Malignant Breas... Malignant Color... Malignant Pancr... Malignant Solid...	Computed Tomogr... Fluorine F 18-f... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients	NCT03168737	Malignant Breas... Malignant Color... Malignant Pancr... Malignant Solid...	Computed Tomogr... Fluorine F 18-f... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center

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