Muscle Invasive Bladder CancerTEP-VessieNCT04053101
Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer
An observational study of Muscle Invasive Bladder Cancer, run by Institut Bergonié at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer
- What is being tested?
- PET CT
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2017to 31 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076
Institut Bergonie
Bordeaux, 33076
About this study
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.
Read the 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).
- Conditions
- Muscle Invasive Bladder Cancer
- Being tested
- PET CT
- Keywords
- Bladder cancer, PET CT, CT scan, Lymph node staging, TNM staging
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET CTDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| MIBC | Patients with muscle invasive bladder cancer (MIBC) Receives: Device: PET CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Date of pathological results, up to 20 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Apr 2017
- Primary completion31 Dec 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053101
- Sponsor's protocol ID
- IB2018-TEP vessie
- Other IDs
- MR 3316040319
- Acronym
- TEP-Vessie
- Status last verified
- Sep 2025
- First submitted
- 4 Jul 2019
- Last updated
- 18 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35101381
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04053101
- Acronym / sponsor ID
- TEP-Vessie / IB2018-TEP vessie
- Conditions
- Muscle Invasive Bladder Cancer
- Keywords
- Bladder cancer, PET CT, CT scan, Lymph node staging, TNM staging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Posted 18 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIBC | – | Device: PET CTPatients with muscle invasive bladder cancer (MIBC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET CTEvery 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). | Device | MIBC |
Primary outcome
Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate
Time frame: 16 weeks after inclusion
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
Accuracy of the PET CT for Lymph Node Staging in Terms of Specificity Rate
Time frame: Date of pathological results, up to 20 weeks after inclusion
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35101381Bertolaso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Invasive Bladder Cancer, run by Institut Bergonié at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate (time frame: 16 weeks after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04053101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.