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

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.

Inclusion Criteria:

• Patients with histopathologic diagnosis of a solid tumor. All solid tumors will be considered, but patients with breast, pancreas, and colorectal masses will be prioritized.
• Patient must have a solid tumor with a short-axis greater than or equal to 1 cm (by CT, magnetic resonance imaging [MRI], ultrasonography or mammography) to allow reliable PET imaging.
• A patient who has not received systemic or loco-regional treatment of the tumor within the last month.
• Ability of the subject, or the legally authorized representative (LAR) if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, to understand, and the willingness to sign, a written informed consent.
• Patients who are not expected to receive cancer therapy before imaging sessions are completed.

Exclusion Criteria:

• Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F] FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before accrual after informed consent is obtained.
• Lactation should be suspended for at least two days following the administration of [18F] FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
• Subjects with contraindications to the use of [18F] FAZA including confirmed allergy.
• Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which precludes their entry into the bore of the PET/CT scanner, because the findings will probably be compromised in image quality with CT, PET/CT and MRI.
• Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.