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FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer

FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer

Recruiting
18-80 years
All
Phase N/A

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Overview

The aim of this trial is to investigate the value of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC and predicting the efficacy of neoadjuvant therapy for MIBC patients, so as to guide the clinic to adjust the treatment plan in time and benefit MIBC patients.

Description

The MIBC diagnostic study was a prospective trial. According to the inclusion and exclusion criteria, patients with suspected MIBC were enrolled and underwent FAPI PET/MRI, FDG PET/MRI and MRI examination, and the imaging data and clinical laboratory and pathologic data were collected, and the postoperative pathological results were used as the gold standard to compare the accuracy of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC.

The MIBC neoadjuvant therapy efficacy assessment study was a prospective trial. Patients with MIBC were enrolled according to the inclusion and exclusion criteria, the regimen was selected individually according to the patient's condition, and the indicators were followed up until the end of time or the occurrence of an endpoint event to obtain information on survival time. FAPI PET/MRI, FDG PET/MRI and MRI were performed once before the start of neoadjuvant therapy and once after the end of therapy, and after the end of neoadjuvant therapy, patients received transurethral cystectomy of bladder tumors or radical cystectomy according to the efficacy and condition, and the combination of the imaging data and the clinical laboratory and pathological data were used to compare FAPI PET/MRI, FDG PET/ MRI and MRI in the assessment of the efficacy of neoadjuvant therapy in MIBC patients to guide clinical treatment options.

Eligibility

Inclusion Criteria:

  • Inclusion criteria for MIBC diagnostic studies
    1. Patients with suspected muscle-invasive bladder cancer;
    2. Completion of FAPI PET/MRI, FDG PET/MRI and MRI;
    3. Complete clinical laboratory and pathological data.
  • Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study
    1. Patients diagnosed with muscle invasive bladder cancer;
    2. Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy;
    3. Complete clinical laboratory and pathological data.

Exclusion Criteria:

  • Exclusion criteria for MIBC diagnostic study
    1. Combined with other malignant tumors;
    2. Not receiving surgical treatment;
    3. Receiving neoadjuvant therapy before surgery;
    4. Previous allergy to contrast components or similar components;
    5. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities;
    6. Incomplete clinicopathological data
  • Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study
    1. Combination of other malignant tumors;
    2. FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy;
    3. Prior hypersensitivity to contrast components or similar components;
    4. Serious organ function abnormalities, such as serious abnormalities of heart, lung, liver and kidney function;
    5. Incomplete clinicopathological data.

Study details
    Urinary Bladder Neoplasms

NCT06421142

First Affiliated Hospital of Fujian Medical University

16 October 2025

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