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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00612326
Collaborator
(none)
26
1
45
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: MRI and PET scanning procedures

Study Design

Study Type:
Observational
Actual Enrollment :
26 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging
Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
1

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Bernard Bochner, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00612326
Other Study ID Numbers:
  • 03-024
First Posted:
Feb 11, 2008
Last Update Posted:
Dec 18, 2015
Last Verified:
Dec 1, 2015

Study Results

No Results Posted as of Dec 18, 2015