3 Tesla MRI in Patients With Bladder Cancer
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
recurrent bladder cancer, stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer
Study Type
Study Phase
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: Specimen Ultra-High field MRI Type: Procedure
Name: chemotherapy Type: Drug
Name: Cystectomy and Lymphadenectomy Type: Procedure
Overall Status
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


- 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.


- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Ohio State University Medical Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Michael Knopp, MD, PhD - 614-293-9998 - knopp.16@osu.edu
Start Date
May 2009
Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page