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

Completed

• Conditions: Transitional Cell Carcinoma; Bladder Cancer
• Interventions: Procedure: MRI and PET scanning procedures

• Registration Number: NCT00612326
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-02-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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.)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	MRI and PET scanning procedures	Patients with newly diagnosed locally or regionally advanced transitional cell carcinoma of the bladder.

Primary Outcome Measures

Name	Time	Method
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.	conclusion of the study

Secondary Outcome Measures

Name	Time	Method
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.	conclusion of the study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States