NCT00938145

3 Tesla MRI in Patients With Bladder Cancer

Imaging of Bladder Cancer Using Clinical 3 Tesla MRI and EX-VIVO Ultra-High-Field MRI.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	Specimen Ultra-High field MRI	Immediately following removal of the bladder and lymph nodes, the specimens will be transported to the ultra-high-field MRI scanner for high resolution imaging.
DRUG	chemotherapy	The majority of patients will be candidates to receive neoadjuvant chemotherapy prior to radical cystectomy as part of standard clinical care. Patients will most often receive cisplatin based therapy for a period of three months (four 21 day cycles).
PROCEDURE	Cystectomy and Lymphadenectomy	The patient will undergo radical cystectomy and pelvic lymph node dissection with no deviation from standard surgical care. A urinary tract reconstruction will follow as either a continent or incontinent form of diversion.

Timeline

• Start date: 2009-07-08
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2009-07-13
• Last updated: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study