3 Tesla MRI in Patients With Bladder Cancer
Conditions
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
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Specimen Ultra-High field MRI Type: Procedure
Name: chemotherapy Type: Drug
Name: Cystectomy and Lymphadenectomy Type: Procedure
Overall Status
Recruiting
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.
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.
Location
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
Sponsors
Ohio State University Comprehensive Cancer Center
Source
Ohio State University Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page