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

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00612326
First received: January 28, 2008
Last updated: March 26, 2008
Last verified: March 2008

January 28, 2008
March 26, 2008
June 2004
March 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00612326 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
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Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging
Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients will be recruited through the outpatient clinics of the Departments of Urology and Medical Oncology of MSKCC.

  • Bladder Cancer
  • Transitional Cell Carcinoma
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.
1
Patients with newly diagnosed locally or regionally advanced transitional cell carcinoma of the bladder.
Intervention: Procedure: MRI and PET scanning procedures
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
March 2008
March 2008   (final data collection date for primary outcome measure)

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.)
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00612326
03-024
Not Provided
Bernard Bochner, MD, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Bernard Bochner, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP