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.
- 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
- 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
- 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
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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||Start Date: May 2009||N/A||Interventional|
Primary Outcome 1 - Measure: Agreement in tumor staging between pathology and 3 Tesla MRI
Primary Outcome 1 - Time Frame: up to 24 months
- 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).
- 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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Michael V. Knopp, MD, PhD
Role: Principal Investigator
Affiliation: Ohio State University Comprehensive Cancer Center
Name: Ohio State University Comprehensive Cancer Center
Link: The Jamesline
|Ohio State University Medical Center
Columbus, Ohio 43210
Michael Knopp, MD, PhD