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

Muscle Invasive Bladder Cancer Clinical Trial

— TEP Vessie  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04053101
• Other study ID #: IB2018-TEP vessie
• Secondary ID: MR 3316040319
• Status: Active, not recruiting
• Start date: April 1, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: August 2019
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: August 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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).

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Institut Bergonie	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of treatment modification according to PET CT results	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
Primary	Evaluation of the accuracy of the PET CT for lymph node staging	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	Comparison of PET CT and CT scan for lymph node and metastatic staging	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
Secondary	Evaluation of FDG PET-CT results as a predictive factor for Pathological Complete Response	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
Secondary	Evaluation of Metabolic Response as a predictive factor for Recurrence Free Survival	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