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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adults aged 18 years or older Previously known oncological disease Histologically confirmed diagnosis of high-grade MIBC Non-muscle-invasive, or low-grade bladder cancer
Eligible for platinum-based neoadjuvant treatment on clinical evaluation:
* ECOG performance status of 0-1,
* creatinine clearance of at least 60 mL/min,
* absence of comorbidities that would contraindicate chemotherapy (such as grade ≥2 neuropathy, grade ≥2 hearing impairment, or significant cardiopathy) Impossibility to perform imaging procedures, including
* Claustrophobia
* history of iodinated contrast medium allergy precluding ceCT
* diabetes uncontrolled by medications Sign of informed consent
Exclusion Criteria:
* Adults aged 18 years or older Previously known oncological disease Histologically confirmed diagnosis of high-grade MIBC Non-muscle-invasive, or low-grade bladder cancer
Eligible for platinum-based neoadjuvant treatment on clinical evaluation:
* ECOG performance status of 0-1,
* creatinine clearance of at least 60 mL/min,
* absence of comorbidities that would contraindicate chemotherapy (such as grade ≥2 neuropathy, grade ≥2 hearing impairment, or significant cardiopathy) Impossibility to perform imaging procedures, including
* Claustrophobia
* history of iodinated contrast medium allergy precluding ceCT
* diabetes uncontrolled by medications
Primary outcome measure(s)
Baseline Diagnostic Accuracy of [18F]FDG PET/CT in MIBC — At baseline, prior to initiation of neoadjuvant therapy (each cycle has a duration of 21 days) 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.
Interim [18F]FDG PET/CT Prediction of Pathological Response — After 2 cycles of neoadjuvant therapy, prior to surgery (each cycle has a duration of 21 days) 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.
Trial sites (1)
Facility
City
Region
Status
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara
Italy
Recruiting
More University Hospital of Ferrara trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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