Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer (MIBC-PET)

August 4, 2026 updated by: University Hospital of Ferrara

Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study

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 Overview

Status

Recruiting

Conditions

Muscle-invasive Bladder Cancer

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Ferrara, Italy, 44124
    - Recruiting
    - Azienda Ospedaliero-Universitaria di Ferrara
    - Contact:
      
      Luca Urso, MD
      
      Phone Number: +390532236906
      
      Email: luca.urso@unife.it
    - Contact:
      
      Francesca Canella
      
      Email: francesca.canella@ausl.fe.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	After 2 cycles of neoadjuvant therapy, prior to surgery (each cycle has a duration of 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 6, 2026

Study Record Updates

Last Update Posted (Actual)