Clinical trial · Observational
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle-invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- adults with high-grade MIBC
- description
- adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC
Primary outcomes (2)
- measure
- Baseline Diagnostic Accuracy of [18F]FDG PET/CT in MIBC
- timeFrame
- At baseline, prior to initiation of neoadjuvant therapy (each cycle has a duration of 21 days)
- description
- 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.
- measure
- Interim [18F]FDG PET/CT Prediction of Pathological Response
- timeFrame
- After 2 cycles of neoadjuvant therapy, prior to surgery (each cycle has a duration of 21 days)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available