Clinical trial · Interventional
Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle-invasive Bladder Cancer | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole-body FDG PET-CT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Whole-body FDG PET-CT
- description
- Whole-body FDG PET-CT (Experimental arm)
- interventionNames
- Other: Whole-body FDG PET-CT
- type
- NO_INTERVENTION
- label
- No PET-CT
- description
- No PET-CT (Control arm)
Primary outcomes (1)
- measure
- Treatment received
- timeFrame
- 5 years
- description
- For patients with planned cystectomy, treatment received includes: avoidance of planned cystectomy and node dissection, an extended (vs standard) node dissection (or standard dissection when extended is the surgeon's usual practice), use of neoadjuvant chemotherapy (vs no neoadjuvant chemotherapy). For patients with planned bladder conservation, treatment received includes: avoidance of bladder and nodal radiation (vs bladder only or no radiation) and use of neoadjuvant chemotherapy (or not).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Age \< 18 years. * ECOG performance status \>2. * Predominant histology (\>50% of specimen) involves non-urothelial cell carcinoma. * 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. * Contraindications to FDG PET-CT. * Inability to lie supine for imaging with PET-CT. * Inadequate hepatic function: (i) Bilirubin \>1.5 X ULN and (ii) SGOT and Alkaline phosphatase \>3 X ULN * History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer. * Known pregnancy or lactating female. * Inability to complete the study or required follow-up.
References
Publications (0)
Data not yet available