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

INTRODUCTION

  • Org Study ID: OSU-08063
  • Secondary ID: NCI-2012-00937
  • NTC ID: NCT00938145
  • Sponsor: Ohio State University Comprehensive Cancer Center
The Jamesline

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.

  • Overall Status
    Recruiting
  • Start Date
    May 2009
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Agreement in tumor staging between pathology and 3 Tesla MRI

Primary Outcome 1 - Timeframe: up to 24 months

CONDITION

  • Bladder Cancer

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Michael V. Knopp, MD, PhD

Role: Principal Investigator

Affiliation: Ohio State University Comprehensive Cancer Center

Overall Contact

Name: Michael V. Knopp, MD, PhD

Phone: 1-800-293-5066, 614-293-9998

Email: OSUCCCClinicaltrials@osumc.edu

LOCATION

Facility Status Contact
Facility: Ohio State University Medical Center
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Michael Knopp, MD, PhD
614-293-9998
knopp.16@osu.edu