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OpenTrials
Completed

NCT Number: NCT00612326

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

MRI and PET scanning procedures

Procedure

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.

Primary outcomes

  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.

    Time frame: conclusion of the study

Secondary outcomes

  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.

    Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 11, 2008
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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