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Brief Title: Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
Official Title: Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
Study ID: NCT02462239
Brief Summary: Bladder cancer is the fifth most common cancer in Canada and there has been relatively little progress in altering its clinical course over the last three decades. One of the major problems identified in the management of this disease, is under staging of muscle invasive disease which can lead to suboptimal treatment and outcomes. PET-CT has the potential to more accurately stage MIBC than standard CT by detecting pelvic adenopathy and/or distant sites of disease that may not be found on standard imaging. In the former situation, more aggressive therapy with extended lymph node dissection and/or neoadjuvant chemotherapy prior to cystectomy can be offered. While in the latter situation patients can be spared the morbidity of a cystectomy performed in a setting of metastatic disease. This study will address whether PET-CT adds a clinically meaningful difference in care.
Detailed Description: A multicenter randomized controlled trial will be performed. Patients usually present with symptoms (e.g., painless hematuria). The urologist will perform cystoscopy and if urothelial cancer of the bladder is suspected, the patient is taken to the operating room for an examination under anesthesia (EUA) and a TURBT. If this shows muscle invasion then conventional staging with CT chest, abdomen, and pelvis is performed. The patient who has TNM Stage T2a-T4a N0-3 M0 is eligible to be enrolled in the trial. Eligible consenting patients will be randomized 2:1 to PET-CT or none (Control). The actual treatment received by the patient will be documented. The primary outcome measure is treatment received.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Regional Cancer Centre, London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Name: Srikala Sridhar, MD
Affiliation: Princess Margaret Hospital, Canada
Role: PRINCIPAL_INVESTIGATOR
Name: Nicholas Power, MD
Affiliation: LHSC-Victoria Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Som Mukherjee, MD
Affiliation: Juravinski Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Ur Metser, MD
Affiliation: Princess Margaret Hospital, Canada
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Levine, MD
Affiliation: Ontario Clinical Oncology Group (OCOG)
Role: STUDY_DIRECTOR