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

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 15
• Participant gender: All

Summary

This goal of this clinical research study is to learn the best time to have a PET-CT scan after receiving (18)F-fluoroazomycin arabinoside ([18F]FAZA).

During certain types of scans (like PET-CT scans), an "imaging agent" is injected into your bloodstream to help certain parts of your body be more clearly seen during the scan. [18F]FAZA is a new imaging agent designed to show how much oxygen is in a tumor during a PET-CT scan.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Last Updated: 2017-07-12

Criteria

Inclusion Criteria:

1. 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.

2. Patient must have a solid tumor with a short-axis greater than or equal to 1 cm (by CT, MRI, ultrasonography or mammography) to allow reliable PET imaging.

3. A patient who has not received systemic or loco-regional treatment of the tumor within the last month.

4. 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.

5. Patients who are not expected to receive cancer therapy before imaging sessions are completed.

Exclusion Criteria:

1. 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.

2. 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.

3. Subjects with contraindications to the use of [18F]FAZA including confirmed allergy.

4. Patients with a body weight of 400 pounds or more, or a 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.

5. Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.

6. Children below the age of 18 are excluded because of the unknown but potential risk.