Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer
ConditionMuscle-invasive Bladder Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Ferrara
About this trial
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 criteria
Qualifiers
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
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
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
60 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov