N/A Completed N=130

Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer

Muscle-Invasive Bladder Cancer

Source: ClinicalTrials.gov NCT04053101 ↗

Enrolled (actual)

130

Serious AEs

—

Results posted

Sep 2025

Primary outcomePrimary: Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate — 21 Participants

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.

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	—

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

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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. Informational only — not medical advice.