Actively Recruiting
Application Research of FAPI PET/MRI, 18F-Fluorodeoxyglucose (FDG) PET/MRI, and MRI in Diagnosing Muscle-Invasive Bladder Cancer and Evaluating Neoadjuvant Therapy Efficacy
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2026-06-01
80
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of FAPI PET/MRI, FDG PET/MRI, and MRI imaging techniques to diagnose muscle-invasive bladder cancer (MIBC) and predict how well patients respond to neoadjuvant therapy. The study aims to help doctors adjust treatment plans in a timely manner to benefit patients with MIBC. This prospective trial collects imaging data alongside clinical laboratory and pathological results to compare the accuracy of these imaging methods using postoperative pathology as the standard. Participants with suspected MIBC undergo FAPI PET/MRI, FDG PET/MRI, and MRI scans to assess diagnosis accuracy. Patients confirmed with MIBC then receive these imaging exams both before and after neoadjuvant therapy. Following therapy, patients have either transurethral tumor resection or radical cystectomy based on treatment response and condition. The study compares imaging and clinical data to evaluate how well these methods assess therapy effectiveness and guide treatment decisions. During the study, participants will have imaging exams, clinical laboratory tests, and pathological assessments. Researchers monitor diagnostic accuracy measures such as sensitivity, specificity, and predictive values within one week after surgical pathology results. They also evaluate therapy response outcomes like remission and metabolic response within one month. Long-term outcomes including overall survival and progression-free survival are followed for one to three years. The study runs until June 2029, and all data will help improve diagnosis and treatment monitoring for MIBC patients.
CONDITIONS
Brief Title
FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with suspected muscle-invasive bladder cancer for the diagnostic study
- Completion of FAPI PET/MRI, FDG PET/MRI, and MRI imaging
- Complete clinical laboratory and pathological data
- Patients diagnosed with muscle-invasive bladder cancer for the neoadjuvant therapy efficacy study
- Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy
- Complete clinical laboratory and pathological data
You will not qualify if you...
- Presence of other malignant tumors
- Not receiving surgical treatment
- Receiving neoadjuvant therapy before surgery
- Allergy to contrast or similar components
- Serious heart, lung, liver, or kidney function abnormalities
- Incomplete clinical or pathological data
- Failure to complete FAPI PET/MRI, FDG PET/MRI, and MRI after neoadjuvant therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week
Participants with suspected muscle-invasive bladder cancer undergo imaging examinations including FAPI PET/MRI, FDG PET/MRI, and MRI to diagnose their condition. Clinical laboratory and pathological data are also collected.
1 visit (in-person)
Duration - Duration of neoadjuvant therapy until completion
Participants diagnosed with muscle-invasive bladder cancer receive individually selected neoadjuvant therapy. Imaging examinations (FAPI PET/MRI, FDG PET/MRI, and MRI) are performed before and after therapy to evaluate treatment efficacy.
2 visits (in-person) for imaging before and after therapy
Duration - Until surgical procedure completion
After neoadjuvant therapy, participants undergo transurethral cystectomy or radical cystectomy based on therapy response and clinical condition.
1 visit (in-person) for surgery
Duration - 1 to 3 years after treatment
Participants are followed up to monitor survival and disease progression after treatment.
Periodic visits for survival and disease status monitoring
Trial Site Locations
Total: 1 location
1
first hospital affiliated of Fujian medical university
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
N
Ning Xu, Doctor
X
Xiao-Dong Li, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
6
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