Muscle-invasive Bladder Cancer
Conditions
Keywords
muscle-invasive bladder cancer, PET/CT, 18F-FDG PET, neoadjuvant chemotherapy, diagnostic accuracy, radiomics, artificial intelligence
Brief summary
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.
Interventions
None listed
Sponsors
University Hospital of Ferrara
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed