Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: 3 Tesla MRI in Patients With 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.

Detailed description: 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: 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.

Relevance to patient case: not relevant