Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Baseline Diagnostic Accuracy of [18F]FDG PET/CT in MIBC
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
adults with high-grade MIBC
adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC
Outcomes
Primary Outcomes
Baseline Diagnostic Accuracy of [18F]FDG PET/CT in MIBC
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported