3 Tesla MRI in Patients With Bladder Cancer

Not Applicable

Active, not recruiting

• Conditions: Bladder Cancer
• Interventions: Procedure: Specimen Ultra-High field MRI; Drug: chemotherapy; Procedure: Cystectomy and Lymphadenectomy

• Registration Number: NCT00938145
• Lead Sponsor: University of Cincinnati

Brief 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.

Study Timeline

• Study Start: 2009-07-08
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI+surgery	Specimen Ultra-High field MRI	3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI
MRI+surgery+chemotherapy	chemotherapy	3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy
MRI+surgery	Cystectomy and Lymphadenectomy	3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI
MRI+surgery+chemotherapy	Specimen Ultra-High field MRI	3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy
MRI+surgery+chemotherapy	Cystectomy and Lymphadenectomy	3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy

Primary Outcome Measures

Name	Time	Method
Agreement in tumor staging between pathology and 3 Tesla MRI	up to 24 months

Secondary Outcome Measures

Name	Time	Method
Agreement in lymph node staging between pathology and 3 Tesla MRI	up to 24 months

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States