RecruitingNot ApplicableNCT06421142

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

Application Research of FAPI Positron Emission Tomography(PET)/MRI, 18F-Fluorodeoxyglucose (FDG) PET/MRI, and MRI in the Diagnosis of Muscular Invasive Bladder Cancer and Evaluation of Neoadjuvant Therapy Efficacy

Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

80 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Urinary Bladder Neoplasms

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

Patients with suspected muscle-invasive bladder cancer;
Completion of FAPI PET/MRI, FDG PET/MRI and MRI;
Complete clinical laboratory and pathological data.
Patients diagnosed with muscle invasive bladder cancer;
Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy;
Complete clinical laboratory and pathological data.

Exclusion Criteria11

Combined with other malignant tumors;
Not receiving surgical treatment;
Receiving neoadjuvant therapy before surgery;
Previous allergy to contrast components or similar components;
Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities;
Incomplete clinicopathological data
Combination of other malignant tumors;
FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy;
Prior hypersensitivity to contrast components or similar components;
Serious organ function abnormalities, such as serious abnormalities of heart, lung, liver and kidney function;
Incomplete clinicopathological data.

Interventions

PROCEDUREimaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg. MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.