Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06421142

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Neoadjuvant Therapy and Imaging

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

Surgery

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

Follow-up and Survival Monitoring

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

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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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