NCT07750470Recruiting
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- 16 Apr 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- University Hospital of Ferrara
- Diseases
- Bladder cancer
- NCT number
- NCT07750470
What you commit to
- Study type: Observational
- Planned participants: 60
- From 16 Apr 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
Other illness
- 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
Lab values
- creatinine clearance of at least 60 mL/min,
Other
- ECOG performance status of 0-1,
- Claustrophobia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria di Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.