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.
Inclusion criteria for MIBC diagnostic studies
Patients with suspected muscle-invasive bladder cancer;
Completion of FAPI PET/MRI, FDG PET/MRI and MRI;
Complete clinical laboratory and pathological data.
Exclusion criteria for MIBC diagnostic study
Combined with other malignant tumors;
Not receiving surgical treatment;
Receiving neoadjuvant therapy before surgery;
Parallel
imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
Procedure/SurgeryFAPI 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.
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Treatment groupsSee each treatment group below.
Diagnostic Sensitivity
It is the percentage of patients who will be correctly judged as positive (true positive) if they actually have muscle invasive bladder cancer. The formula is TP/(TP+FN)×100%.TP is true positive and FN is false negative.
Diagnostic Specificity
the percentage of patients who are not actually suffering from muscle invasive bladder cancer correctly judged as negative (true negative). The formula is TN/(TN+FP)×100%.TN is true negative, FP is false positive.
Positive Expected Value (PPV)
the ratio of true positives among the positive results obtained by a specific test method. The formula is: PPV=TP/(TP+FP)×100%.
Negative Expected Value (NPV)
refers to the ratio of true negatives among the negative results obtained by a specific test method. The formula is: NPV=TN/(TN+FN)×100%.
Overall Survival (OS)
the duration from the time a patient receives systemic therapy to the time of death from any cause.
Radiographic Progression Free Survival (rPFS)
the duration from the start of treatment to the occurrence of imaging progression or death due to any cause (whichever occurs first). Conventional imaging (RECIST 1.1 criteria), and FAPI PET/MRI (PERCIST 1.0 criteria) were used to assess the imaging progression of patients after receiving treatment, respectively.
Overall Remission Rate (Objective Response Rate, ORR)
usually includes patient cases with CR+PR. Among them, conventional imaging was used to assess the proportion of patients meeting the criteria for CR or PR using the RECIST 1.1 criteria; FAPI PET/MRI was used to assess the proportion of patients meeting the criteria for CR or PR using the PERCIST 1.0 criteria;
Disease Control Rate (DCR)
usually includes the proportion of patients with CR+PR+SD. Among them, conventional imaging uses RECIST 1.1 criteria to assess the proportion of patients meeting the criteria of CR or PR or SD; FAPI PET/MRI uses PERCIST 1.0 criteria to assess the proportion of patients meeting the criteria of CR or PR or SD.
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