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

NCT ID: NCT04053101

Last Updated: 2025-09-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Muscle Invasive Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MIBC

Patients with muscle invasive bladder cancer (MIBC)

PET CT

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Bordeaux

Bordeaux, , France

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Countries

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France

References

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Bertolaso P, Brouste V, Cazeau AL, de Clermont-Gallerande H, Bladou F, Cabart M, Lefort F, Gross-Goupil M. Impact of 18 FDG- PET CT in the Management of Muscle Invasive Bladder Cancer. Clin Genitourin Cancer. 2022 Jun;20(3):297-297.e6. doi: 10.1016/j.clgc.2022.01.009. Epub 2022 Jan 14.

Reference Type RESULT
PMID: 35101381 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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MR 3316040319

Identifier Type: OTHER

Identifier Source: secondary_id

IB2018-TEP vessie

Identifier Type: -

Identifier Source: org_study_id

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