A Pilot Study of 18Fluorine-Fluciclovine Positron Emission Tomography/Computed Tomography for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy.

This research study is studying a positron emission tomography (PET) agent called
18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of
muscle invasive bladder cancer (as compared to regular CT and MRI imaging) and whether
18F-fluciclovine-PET scans can provide information about the pathologic grade of the tumor.

Inclusion Criteria:

- Participants must have histologically or cytologically confirmed urothelial carcinoma
of the bladder.

- Participants must have cT2-T4N0 disease at the time of the study, as defined by
conventional CT or MRI imaging. Patients must have no definite evidence of
locoregional or distant metastatic disease at the time of study eligibility, as
defined by conventional imaging.

- Radical cystectomy must be planned for the patient after the planned
18F-fluciclovine-PET/CT.

- Patients may or may not have had prior neoadjuvant therapy prior to this study.

- Age ≥18 years. Since no dosing or adverse event data are currently available on the
use of 18F-fluciclovine in participants <18 years of age, and the majority of bladder
cancer occur in the adult population [42], children are excluded from this study but
will be eligible for future pediatric trials.

- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)

- Ability and willingness to comply with the study procedures.

- The effects of 18F-fluciclovine on the developing human fetus are unknown. For this
reason and because radiopharmaceuticals may be teratogenic, women of childbearing
potential and men must agree to use adequate contraception (barrier method of birth
control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is
completed. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Participants with other known malignancies that has required treatment in the past 3
years.

- Pregnant women are excluded from this study because 18F-fluciclovine is a
radiopharmaceutical with the potential for teratogenic effects. Because of the
radiation exposure to a nursing infant from 18F-fluciclovine, women who are
breastfeeding are also excluded from this study.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to 18F-fluciclovine.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Contraindications for PET/CT including:

- Severe claustrophobia

- Any past or current condition that in the opinion of the study investigators would
confound the results of the study or pose additional risk to the patient by their
participation in the study