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NCT Number: NCT04053101

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

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.

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Key information

Conditions

Muscle Invasive Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

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About this study

Background:

Bladder cancer is the second most frequent genito-urinary cancer, and the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years. Curative treatment of muscle invasive urothelial carcinoma localized to the bladder includes cisplatin-based neoadjuvant chemotherapy, followed by radical cystectomy with lymph nodes dissection. Nonetheless, surgery indications depend on pre-operative staging regarding nodes and metastatic involvement.

Computed Tomography (CT) scan is the reference imaging study for loco-regional and metastatic staging. Lymph node involvement evaluation is based on morphologic criteria only. Its sensitivity lies between 30 and 53% and its specificity between 67 and 91%. Yet, optimal node staging is crucial for therapeutic decision.

FDG-Positron Emission Tomography (PET) CT, using both morphologic and functional criteria, could help for node staging in muscle invasive bladder cancer assessment, especially by detecting infracentimetric involved lymph nodes. Moreover, it could be useful for detecting distant metastasis.

Objective: To evaluate the accuracy of the PET CT for lymph node staging and to determine the rate of treatment modification according to PET CT results Methods: Retrospective study based on the medical records of every patient undergoing a PET CT at the time of diagnosis of MIBC from 01/2005 to 12/2017 in Bordeaux (Bergonie Institute and University Hospital). PET CT could have been done before any treatment (PET 1) and/or after neo-adjuvant chemotherapy and before surgery (PET 2).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET CT

Device

Every patient undergoing a PET CT at the time of diagnosis of muscle invasive bladder cancer from January 2005 to December 2017 in Bordeaux (Institut Bergonié and University Hospital).

Primary outcomes

  1. Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate

    Time frame: 16 weeks after inclusion

    Performance sensitivity of FDG-PET CT for LN staging on diagnosis of MIBC (before and after NAC and before cystectomy and LN dissection).

    Gold standard : pathological results (complete response vs no complete response).

    Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response.

    Sensitivity rate : count of participants with complete response as per FDG-PET divided by count of participants with pathoplogical complete response

  2. Accuracy of the PET CT for Lymph Node Staging in Terms of Specificity Rate

    Time frame: Date of pathological results, up to 20 weeks after inclusion

    Performance specificity of FDG-PET CT for LN staging on diagnosis of MIBC (before and after NAC and before cystectomy and LN dissection).

    Gold standard : pathological results (complete response vs no complete response).

    Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response Specificiity rate : count of participants with NO complete response as per FDG-PET divided by count of participants with NO pathoplogical complete response

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Acronym: TEP-Vessie

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 12, 2019
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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