3 Tesla MRI in Patients With Bladder Cancer

OBJECTIVES:

Primary

- To evaluate whether 3 Tesla MRI can accurately determine the primary tumor (T) stage and
pelvic lymph nodes (N) stage in patients with localized bladder cancer as compared to
histopathology staging.

Secondary

- To determine whether 3 Tesla MRI can determine if the primary bladder tumor is
responding to neoadjuvant chemotherapy at the mid-point of the planned treatment (after
2 courses).

- To assess whether an ex-vivo ultra-high-field MRI (4.7-11.7 Tesla) tissue scan can more
accurately determine clinical stage of a primary bladder tumor and local extent of the
disease (i.e., involvement of contiguous organs and regional lymph nodes) as compared to
histopathology staging.

OUTLINE: Patients may receive neoadjuvant chemotherapy (typically four 21-day courses of
cisplatin-based therapy) followed by standard radical cystectomy and lymph node dissection.

Patients undergo a 3 Tesla MRI scan at baseline to stage the primary tumor, regional lymph
nodes, and to rule out distant sites of disease. The MRI includes diagnostic high-resolution
anatomical images (e.g., T1-weighted and T2-weighted images along axial or optimal
directions) and experimental images including functional MRI (e.g., dynamic contrast-enhanced
MRI, diffusion-weighted MRI, MR spectroscopy, and chemical exchange-dependent
saturation-transfer imaging). Patients also undergo a 3 Tesla MRI scan after 2 courses of
neoadjuvant chemotherapy and after completion of neoadjuvant chemotherapy. Patients not
receiving neoadjuvant chemotherapy undergo a 3 Tesla MRI scan 2-4 weeks before radical
cystectomy and lymph node dissection.

Specimens from the radical cystectomy and pelvic lymph node dissection are examined ex-vivo
by ultra-high-field MRI and the Micro-Imaging Specimen Study Form is completed. The specimens
are then examined by the pathology department as per standard routine.

Inclusion Criteria:

- Known bladder cancer

- Scheduled for radical cystectomy and lymph node dissection.

- Able and willing to give valid written informed consent.

- No contraindications to the MRI(magnetic resonance imaging).

Exclusion Criteria:

- Not pregnant, planning to become pregnant during the study, or nursing.

- No allergy to contrast agents.

- Patient with significant renal insufficiency, i.e. an estimated glomerular filtration
rate(eGRF) less than 30 mL/min/1.73m2.

- Any condition conflict based on the investigation's clinical judgment that would
prevent the patient from completion all trial assessments and visits.

- Inability or unwillingness to cooperate with requirements of this trial.

- Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe
vertigo when they are moved into the MR.

- Patients with sickle cell anemia and other hemolytic anemia.