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| ID | Type | Description | Link |
|---|---|---|---|
| MR 3316040319 | Other Identifier | Institut National des Données de Santé (INDS) |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIBC | Patients with muscle invasive bladder cancer (MIBC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux | 33076 | France | |||
| Institut Bergonie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35101381 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MIBC | Patients with muscle invasive bladder cancer (MIBC) 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MIBC | Patients with muscle invasive bladder cancer (MIBC) 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients with complete pathological response | Posted | Count of Participants | Participants | 16 weeks after inclusion |
|
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events were not collected
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIBC | Patients with muscle invasive bladder cancer (MIBC) 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials Unit | Institut Bergonié | +33556333333 | s.mathoulin@bordeaux.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2017 | Aug 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| Bordeaux |
| 33076 |
| France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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 | Participants with NO pathoplogical complete response | Posted | Number | participants | Date of pathological results, up to 20 weeks after inclusion |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |