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

NCT07750470 | Recruiting

• 1 other identifier: 109/2024/Oss/AOUFe
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Muscle-invasive Bladder Cancer

Keywords

muscle-invasive bladder cancer; PET/CT; 18F-FDG PET; neoadjuvant chemotherapy; diagnostic accuracy; radiomics; artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Baseline Diagnostic Accuracy of [18F]FDG PET/CT in MIBC

  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

  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)

Study Arms (1)

adults with high-grade MIBC

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: August 6, 2026
• Study Start: April 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)