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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612326
• Other study ID #: 03-024
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: December 16, 2015
• Start date: June 2004
• Est. completion date: March 2008

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center