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.
Inclusion Criteria:
Eligible for platinum-based neoadjuvant treatment on clinical evaluation:
Exclusion Criteria:
Eligible for platinum-based neoadjuvant treatment on clinical evaluation:
adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC
Ferrara, 44124, Italy
luca.urso@unife.it+390532236906
francesca.canella@ausl.fe.it
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