Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer (TEP Vessie)

August 9, 2019 updated by: Institut Bergonié

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Bordeaux, France, 33076
        • Centre Hospitalier Universitaire de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of treatment modification according to PET CT results
Time Frame: Date of Multidisciplinary Tumor Board following PET CT, up to 16 weeks after inclusion
Description: Assess differences between planned management before knowing the FDG-PET CT results and treatment actually received.
Date of Multidisciplinary Tumor Board following PET CT, up to 16 weeks after inclusion
Evaluation of the accuracy of the PET CT for lymph node staging
Time Frame: Date of pathological results, up to 20 weeks after inclusion
Comparison of lymph nodes staging on PET CT (according to EORTC criteria) and lymph nodes staging on pathological report, according to the AJCC TNM Staging System for Bladder Cancer 8th ed., 2017.
Date of pathological results, up to 20 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of PET CT and CT scan for lymph node and metastatic staging
Time Frame: Date of the realization of both tests, up to 16 weeks after inclusion
Evaluation of the concordance rate between PET CT results (according to EORTC criteria) and CT scan results (according to RECIST 1.1) for lymph node and metastatic staging according to the AJCC TNM Staging System for Bladder Cancer 8th ed., 2017.
Date of the realization of both tests, up to 16 weeks after inclusion
Evaluation of FDG PET-CT results as a predictive factor for Pathological Complete Response
Time Frame: Date of pathological results, up to 20 weeks after inclusion
Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response
Date of pathological results, up to 20 weeks after inclusion
Evaluation of Metabolic Response as a predictive factor for Recurrence Free Survival
Time Frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 years
Comparison of Recurrence Free Survival for patients with and patients without a Complete Metabolic Response (according to EORTC criteria)
From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Anticipated)

August 31, 2019

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2018-TEP vessie
  • MR 3316040319 (Other Identifier: Institut National des Données de Santé (INDS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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