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

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ClinicalTrials.gov Identifier: NCT04053101
Recruitment Status : Active, not recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

Brief 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.


Condition or disease Intervention/treatment
Muscle Invasive Bladder Cancer Device: PET CT

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).


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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer


Intervention Details:
  • Device: PET CT
    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 Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053101


Locations
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France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076
Institut Bergonie
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié

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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT04053101     History of Changes
Other Study ID Numbers: IB2018-TEP vessie
MR 3316040319 ( Other Identifier: Institut National des Données de Santé (INDS) )
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Bergonié:
Bladder cancer
PET CT
CT scan
Lymph node staging
TNM staging
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases