NCT02462239Completed
Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 292 (actual)
- First submitted
- 27 May 2015
- Start date
- 6 May 2016
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Diseases
- Bladder cancer
- NCT number
- NCT02462239
What you commit to
- Study type: Interventional
- Participants enrolled: 292
- From 6 May 2016 to the primary completion date, 31 Mar 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior partial cystectomy.
- Prior pelvis surgery that obviates a completed extended lymphadenectomy (e.g., aorto-femoral/iliac bypass) or for whom the surgeon feels that their ability to perform a standard or extended pelvic node dissection would be compromised.
Other illness
- History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer.
Lab values
- Inadequate hepatic function:
- (i) Bilirubin \>1.5 X ULN and (ii) SGOT and Alkaline phosphatase \>3 X ULN
Age
- Age \< 18 years.
Other
- ECOG performance status \>2.
- Predominant histology (\>50% of specimen) involves non-urothelial cell carcinoma.
- Contraindications to FDG PET-CT.
- Inability to lie supine for imaging with PET-CT.
- Known pregnancy or lactating female.
- Inability to complete the study or required follow-up.
Who the study is looking for
- Men and women with newly diagnosed muscle-invasive high grade urothelial carcinoma of the bladder (TNM stage T2a-T4a, N0-3, M0), who are eligible for either radical cystectomy or radiotherapy-based bladder conservation.
- Being considered for treatment of curative intent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| London Regional Cancer Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Ottawa Hospital Regional Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Thunder Bay Regional Health Sciences Centre Coordinator of this site? Confirm its status | Thunder Bay | Canada | Unknown status |
| Sunnybrook Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.