Circulating Tumor Cells in Operative Blood in Patients With Bladder Cancer

PRIMARY OBJECTIVES:

I. To detect the numbers of circulating tumor cells (CTCs) during and following radical
cystectomy in both the peripheral and central line.

SECONDARY OBJECTIVES:

I. To ensure the safety and of using the femoral vein to access the central venous blood
supply for patients with primary bladder cancer and the withdrawal of blood from both a
peripheral and central line.

OUTLINE:

Patients undergo placement of a central line via the right femoral vein and undergo open
radical cystectomy (ORC). Blood samples are collected and analyzed for CTCs pre-surgery, at
30 minutes and 1 hour once ORC begins, post-surgery, and 7 days after surgery.

After completion of study, patients are followed up at 2 weeks and at 1 month.

Inclusion Criteria:

- Must meet all inclusion and exclusion criteria

- Presence of a muscle invasive bladder tumor(s) (T2), specific for transitional cell
carcinoma on pre-operative histology (i.e. biopsy or trans-urethral resection of
bladder tumor [TURBT])

- Presence of a single bladder tumor lesion

- Patients are scheduled to undergo ORC at our institution

- Subjects must have given written informed consent to agree to participate

- Previous chemotherapy, and/or biological therapy for cancer are permitted provided
that the acoustic properties of the tumor were not affected, but the subject should
have recovered from the effects of these or of any prior surgery

- Subjects must be free of any clinically significant disease other than cancer that
would interfere with the study evaluations

- Absolute neutrophil count (ANC) >= 1500 mm^-3

- Platelet count >= 100,000 mm^-3

- Hemoglobin >= 10 g/dl

- Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)

- Activated partial thromboplastin time =< 1.5 times ULN

- Total bilirubin < 1.5 times ULN

- Aspartate aminotransferase (AST) =< 3 times ULN

- Alkaline phosphatase < 2 times ULN, unless arising from bone

Exclusion Criteria:

- Subjects deemed unsuitable candidates and not medically optimized for ORC

- Subjects with tumors lying < 1 cm from sensitive structures such as the ureter,
prostate or adjacent bowel

- Patients with presence of multiple bladder lesions

- Patients with pre-operative histologic confirmation of a bladder lesion other than
transitional cell carcinoma

- Subjects on concurrent anticoagulant, or immunosuppressive medication

- Subjects on anti-cancer medication whether biologic or pharmaceutical

- Women who are pregnant or nursing (pregnancy test to be performed within 24 hours
prior to high intensity frequency ultrasound [HIFU] treatment)

- Subjects assessed by consultant anesthetist as unsuitable for general anesthetic

- Absolute Contraindications: venous injury at the level of the femoral veins or
proximally; known or suspected thrombosis of the femoral or iliac veins on the
proposed side of venous annulation, ambulatory patient

- Relative Contraindications: presence of bleeding disorders; distortion of anatomy due
to local injury or deformity; previous long-term venous catheterization; history of
vasculitis; previous injection of sclerosis agents; previous radiation therapy