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

Study Groups and Study Procedures:

If you are found eligible to take part in this study, you will be assigned to 1 of 2 groups
depending on when you join the study. The first 5-8 participants will be enrolled in Group A
and the next 5-8 will be enrolled in Group B.

The study doctor will tell you to which group you have been assigned.

- Group A will have 5 [18F]FAZA PET-CT scans on Day 1 of the study and 5 scans on Day 2.

- Based on what is learned from Group A, Group B will have 5 or less [18F]FAZA PET-CT
scans on Day 1 and will have 5 or less [18F]FAZA PET-CT scans on either Day 3, 4, or 5.

[18F]FAZA will be given by vein as an injection 1 time each day, about 1 hour before the
scans begin. This means you will be injected with [18F]FAZA a total of 2 times while on
study.

There may be a break between each scan. During that time you can get off the scanner, but you
will be monitored for side effects.

Your vital signs will be measured before and about 3 ½ hours after the [18F]FAZA PET-CT scan.

Follow-Up Phone Calls:

You will be called about 24 hours after the [18F]FAZA PET-CT scans and asked about any side
effects you may be having.

You will also be called about 30 days after your last [18F]FAZA PET-CT scan and you will be
asked about any side effects you may have had.

Length of Study:

Your participation in this study will be over after the 30 day follow-up phone call.

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.