Trial Outcomes & Findings for Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer (NCT NCT04053101)
NCT ID: NCT04053101
Last Updated: 2025-09-18
Results Overview
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
COMPLETED
130 participants
16 weeks after inclusion
2025-09-18
Participant Flow
Participant milestones
| Measure |
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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|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
130
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MIBC
n=130 Participants
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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Age, Continuous
|
66 years
n=130 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=130 Participants
|
|
Region of Enrollment
France
|
130 participants
n=130 Participants
|
PRIMARY outcome
Timeframe: 16 weeks after inclusionPopulation: Patients with complete pathological response
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
Outcome measures
| Measure |
Eligible MIBC Patients
n=26 Participants
Patients with pelvic LN dissection and with a FDG-PET CT before neoadjuvant chemotherapy
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|---|---|
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Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate
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21 Participants
|
PRIMARY outcome
Timeframe: Date of pathological results, up to 20 weeks after inclusionPopulation: Participants with NO pathoplogical complete response
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
Outcome measures
| Measure |
Eligible MIBC Patients
n=59 Participants
Patients with pelvic LN dissection and with a FDG-PET CT before neoadjuvant chemotherapy
|
|---|---|
|
Accuracy of the PET CT for Lymph Node Staging in Terms of Specificity Rate
|
32 participants
|
Adverse Events
MIBC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
Institut Bergonié
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place