Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Muscle-invasive Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study
Overview
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.
Primary outcome measures
- 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)]
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Azienda Ospedaliero-Universitaria di Ferrara — Ferrara
Identifiers
NCT: NCT07750470 · 109/2024/Oss/AOUFe