FDG PET/CT for Muscle-Invasive Bladder Cancer: Baseline Staging and Chemotherapy Response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center, non-profit study enrolls 60 adults with newly diagnosed high-grade muscle-invasive bladder cancer. Each participant undergoes baseline imaging with 18F-FDG PET/CT and contrast-enhanced CT, followed by a second PET/CT and CT after two cycles of neoadjuvant therapy. The PET/CT protocol includes standard delayed imaging and an early dynamic pelvic acquisition to reduce urinary tracer interference. Primary endpoints compare PET/CT accuracy against ceCT for initial staging and for predicting pathological response to chemotherapy; secondary endpoints explore early dynamic PET/CT utility for local staging and radiomic/AI-based predictive modeling.

Why it matters

Who can join: the full rules

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

Where it's running

• Azienda Ospedaliero-Universitaria di Ferrara
  Ferrara, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.