Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging

Overview

The purpose of this study is to to find out if the MRI and PET scans can truly stage patients with bladder cancer. Both scans use newer ways to find out if your disease has grown beyond the bladder. The radioactive tracer used for the PET scan is called C-11 Acetate. We want to see if PET scan will be able to take a picture of the inside of your body that is better than other scans such as the CT scan and MRI. Therefore, the findings of the PET scan will be compared with other imaging studies as well as the surgical findings.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2008

Interventions

  • Procedure: MRI and PET scanning procedures
    • a CT scan, MRI, and C-11 Acetate PET scan. All these scans will be done as an outpatient. After you finish these scans, your doctor will schedule you for surgery to remove your bladder and lymph nodes.

Arms, Groups and Cohorts

  • 1
    • Patients with newly diagnosed locally or regionally advanced transitional cell carcinoma of the bladder.

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the logistical and technical parameters that are needed to use 11C acetate-PET, and MRI for the preoperative detection of nodal metastases in patients with invasive bladder cancer.
    • Time Frame: conclusion of the study

Secondary Measures

  • Evaluate the logistical and technical parameters needed to use contemporary pelvic MRI for preop primary tumor staging in pts with invasive disease (>T2) through detailed comparison of MRI imaging and pathologic findings following radical cystectomy.
    • Time Frame: conclusion of the study

Participating in This Clinical Trial

Inclusion Criteria

  • Thirty (30) patients will be enrolled in this pilot study. – All patients will have a clinical or histologic diagnosis of bladder cancer with active disease identified within the bladder at the time of consent and imaging. – Patients with primary resectable lesions, and localized or regionally extensive disease will be eligible with residual disease in the bladder at the time of imaging. – All patients will have consented to treatment at MSKCC Exclusion Criteria:

  • Prior pelvic radiation for bladder cancer – Non-transitional cell histologies – Patients deemed not appropriate surgical candidates – Patients that are pregnant or lactating – Patients that cannot tolerate being in the PET or MRI scanner for the duration of the study. Patients deemed unable to receive a contrast enhance CT will remain eligible. – Vulnerable patients (minors, mentally retarded, prisoners, etc.)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bernard Bochner, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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