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

Fujian Medical University (FJMU)

Status: Enrolling

Conditions: Urinary Bladder Neoplasms

Treatments: Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06421142

2024-041-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 6 patient groups

MIBC diagnostic study-FAPI PET/MRI

Experimental group

Description:

suspected MIBC participants receive FAPI PET/MRI examination after entering the group.

Treatment:

Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

MIBC diagnostic study-FDG PET/MRI

Experimental group

Description:

suspected MIBC participants receive FDG PET/MRI examination after entering the group.

Treatment:

Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

MIBC diagnostic study-MRI

Active Comparator group

Description:

suspected MIBC participants receive MRI examination after entering the group.

Treatment:

Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

MIBC neoadjuvant evaluation study-FAPI PET/MRI

Experimental group

Description:

Patients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy.

Treatment:

Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

MIBC neoadjuvant evaluation study-FDG PET/MRI

Experimental group

Description:

Patients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy.

Treatment:

Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

MIBC neoadjuvant evaluation study-MRI

Active Comparator group

Description:

Patients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy.

Treatment:

Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI