Testing a PET/CT scan for staging and treatment response in muscle-invasive bladder cancer
Compares PET/CT with standard CT scans in adults newly diagnosed with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer
Key facts
- Where
- Ferrara, ItalySee the site
Where in Italy
- Azienda Ospedaliero Universitaria di FerraraFerrara, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital of Ferrara
- Trial code
- NCT07750470
- Record updated
- 6 August 2026
- Original description
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.Read full original descriptionShow less
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study
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: 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: 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:; 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; history of iodinated contrast medium allergy precluding ceCT; diabetes uncontrolled by medications; creatinine clearance of at least 60 mL/min,; ECOG performance status of 0-1,; Claustrophobia.