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

NCT04053101 | Completed Results

• 2 other identifiers: IB2018-TEP vessieMR 3316040319
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscle Invasive Bladder Cancer

Keywords

Bladder cancer; PET CT; CT scan; Lymph node staging; TNM staging

Outcome Measures

Primary Outcomes (2)

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

  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

  16 weeks after inclusion

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

  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

  Date of pathological results, up to 20 weeks after inclusion

Study Arms (1)

MIBC

Patients with muscle invasive bladder cancer (MIBC)

Device: PET CT

Interventions

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).

MIBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (2)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33076, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Related Publications (1)

• 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.

  PMID: 35101381 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
• Organization: Institut Bergonié

s.mathoulin@bordeaux.unicancer.fr

+33556333333

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: August 12, 2019
• Study Start: April 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: August 31, 2019
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)