3 tesla mri in patients with bladder cancer

Conditions: Bladder Cancer

Summary: rationale: new diagnostic procedures, such as 3 tesla magnetic resonance imaging (mri), may help find bladder cancer and learn the extent of disease. purpose: this clinical trial is studying how well 3 tesla mri works in finding cancer 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.

Eligibility criteria:
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.

Keywords: recurrent bladder cancer stage ii bladder cancer stage iii bladder cancer stage iv bladder cancer