N/A
N=130
Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer
Muscle Invasive Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04053101 ↗Enrolled (actual)
130
Serious AEs
—
Results posted
Sep 2025
Primary outcome: Primary: Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate — 21 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PET CT (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Bergonié
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate |
21 | — |
| PRIMARY Accuracy of the PET CT for Lymph Node Staging in Terms of Specificity Rate |
32 | — |
Summary
Bladder cancer is the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years.
Optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (MIBC).
Guidelines do not recommend FDG-Positron Emission Tomography (PET) Computed Tomography (CT), but rather CT for lymph node and metastatic staging, despite its low accuracy. We performed a retrospective analysis of patients undergoing PET CT for localized MIBC in two centers, to help define the utility of PET CT in this setting.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Muscle Invasive Urothelial Carcinoma of the bladder (classified at least pT2 on TURB)
- Diagnosis between January 2005 and December 2017
- PET CT done during initial assessment before surgery (at the time of diagnosis and/or after neoadjuvant chemotherapy)
- Management of cancer at Institut Bergonié or at Bordeaux University Hospital
- Previous treatment for Non Muscle Invasive Bladder Cancer allowed
Exclusion Criteria
- Management of cancer outside of Institut Bergonié or Bordeaux University Hospital
- No PET CT done during initial assessment (before surgery)
- Rare pathological type of bladder cancer without urothelial carcinoma (epidermoid carcinoma, neuro-endocrine carcinoma, …)
- Extra-vesical urothelial carcinoma
Data sourced from ClinicalTrials.gov (NCT04053101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.