Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer
MIBC-PET
MIBC-PET
Sponsor study identifier
observational
60
1 country
1
Study Start
April 16, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
MIBC-PET is a prospective, monocentric, no-profit study with paired imaging comparison enrolling 60 patients with newly diagnosed, histologically confirmed high-grade MIBC. All patients undergo baseline staging with \[18F\]FDG PET/CT and contrast-enhanced CT (ceCT) of chest, abdomen, and pelvis. A second \[18F\]FDG PET/CT and CT are performed after two cycles of neoadjuvant therapy. \[18F\]FDG PET/CT includes both standard delayed imaging and an early dynamic pelvic acquisition to overcome urinary tracer interference. The primary endpoints are (1) diagnostic accuracy of \[18F\]FDG PET/CT versus ceCT for baseline staging, and (2) accuracy of \[18F\]FDG PET/CT in predicting pathological response to neoadjuvant chemotherapy. Secondary endpoints include validation of early dynamic \[18F\]FDG PET/CT for local staging and radiomic/AI-based predictive modeling.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2024
Actual (reported)February 23, 2026
Actual (reported)August 6, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Baseline Diagnostic Accuracy of [18F]FDG PET/CT in MIBC
Assessment of \[18F\]FDG PET/CT for initial staging of newly diagnosed muscle-invasive bladder cancer, compared with thoraco-abdomino-pelvic contrast-enhanced CT (gold standard) to determine diagnostic accuracy in defining disease extent.
At baseline, prior to initiation of neoadjuvant therapy (each cycle has a duration of 21 days)
Interim [18F]FDG PET/CT Prediction of Pathological Response
Evaluation of the ability of interim \[18F\]FDG PET/CT to predict pathological response to neoadjuvant treatment, assessing its potential role in guiding therapeutic decision-making.
After 2 cycles of neoadjuvant therapy, prior to surgery (each cycle has a duration of 21 days)
adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC
adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, 44124, Italy
First Submitted
February 23, 2026
First Posted
August 6, 2026
Study Start
April 16, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 6, 2026
Record last verified: 2026-02
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