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Testing a PET/CT scan for staging and treatment response in muscle-invasive bladder cancer

Compares PET/CT with standard CT scans in adults newly diagnosed with muscle-invasive bladder cancer.

Key facts

Who runs it
University Hospital of Ferrara
Where
Ferrara, ItalySee the site
Trial code
Registry title
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer
Status
Recruiting
People taking part
60 people, planned
Started
16 Apr 2024
Expected to end
Dec 2026
Type of study
Observational
Record updated
6 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed, high-grade bladder cancer that has grown into the muscle, who can receive platinum-based chemotherapy before surgery.

Age
18 years or older
Sex
All sexes can join.
Disease stage
High-grade muscle-invasive bladder cancer, confirmed by tissue examination. Newly diagnosed.

Main reasons for not taking part

  • Non-muscle-invasive or low-grade bladder cancer
  • ECOG performance status above 1
  • Creatinine clearance below 60 mL/min
  • Conditions that rule out chemotherapy, such as grade ≥2 neuropathy, grade ≥2 hearing impairment or significant heart disease
  • Cannot have the imaging tests: claustrophobia, iodinated contrast medium allergy, or diabetes not controlled by medication

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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:
  • 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
  • history of iodinated contrast medium allergy precluding ceCT
  • diabetes uncontrolled by medications
  • creatinine clearance of at least 60 mL/min,
  • ECOG performance status of 0-1,
  • Claustrophobia

Where in Italy

  • Azienda Ospedaliero Universitaria di FerraraFerrara, ItalyContact: Luca Urso, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • adults with high-grade MIBC

    adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study
Plain-language title
Testing a PET/CT scan for staging and treatment response in muscle-invasive bladder cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 August 2026