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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Negative Likelihood Ratio (NLR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study
- •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.
排除标准
- •Exclusion criteria for MIBC diagnostic study
- •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
- •Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study
- •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.
研究组 & 干预措施
MIBC diagnostic study-FAPI PET/MRI
suspected MIBC participants receive FAPI PET/MRI examination after entering the group.
干预措施: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI (Procedure)
MIBC neoadjuvant evaluation study-FDG PET/MRI
Patients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy.
干预措施: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI (Procedure)
MIBC neoadjuvant evaluation study-FAPI PET/MRI
Patients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy.
干预措施: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI (Procedure)
MIBC diagnostic study-FDG PET/MRI
suspected MIBC participants receive FDG PET/MRI examination after entering the group.
干预措施: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI (Procedure)
MIBC diagnostic study-MRI
suspected MIBC participants receive MRI examination after entering the group.
干预措施: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI (Procedure)
MIBC neoadjuvant evaluation study-MRI
Patients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy.
干预措施: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI (Procedure)
结局指标
主要结局
Negative Likelihood Ratio (NLR)
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
the ratio of the probability that a patient who actually has muscle invasive bladder cancer is judged negative to the probability that a patient who actually does not have muscle invasive bladder cancer is judged negative. The formula is: -LR=(1-sensitivity)/specificity×100%.
Youden Index
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
the sum of sensitivity and specificity minus 1. Correct diagnostic index can be used for the comparison of two diagnostic methods, and the ideal correct diagnostic index is 100%. r = (specificity + sensitivity) - 1 = 1 - (false positive rate + false negative rate)
Negative Expected Value (NPV)
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
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%.
Diagnostic Sensitivity
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
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
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
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)
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
the ratio of true positives among the positive results obtained by a specific test method. The formula is: PPV=TP/(TP+FP)×100%.
Positive Likelihood Ratio (PLR)
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
the ratio of the probability that a patient who actually has muscle invasive bladder cancer is judged to be positive to the probability that a patient who actually does not have muscle invasive bladder cancer is judged to be positive. The formula was calculated as +LR = sensitivity/(1-specificity) × 100%.
Progressive Disease (PR)
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
In RECIST 1.1 Efficacy assessment criteria for conventional imaging, PD was defined as an increase in the sum of the largest diameters of the target lesions by at least ≥20% or the emergence of new lesions. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, PD refers to an increase of \>30% in the peak SUL or the appearance of new lesions.
Standardized uptake values peak, maximum, and mean (SUVpeak , SUVmax, SUVmean)
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
changes in SUVmax, SUVmean, and SUVpeak of the tumor lesion before and after treatment obtained from PET/MRI images.
Partial Remission (PR)
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
In RECIST 1.1 Efficacy assessment criteria for conventional imaging, PR was defined as a decrease of ≥30% in the sum of the largest diameters of target lesions for at least 4 weeks. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, PR refers to a decrease of \>30% in the peak SUV.
Tumor-to-Background Ratio (TBR)
时间窗: Within 1 week after obtaining the surgical pathology report and imaging report results
changes in the ratio of the radioactivity of tumor tissue to the radioactivity of background tissue obtained from PET/MRI images before and after treatment.
Stable Disease (SD)
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
In RECIST 1.1 Efficacy assessment criteria for conventional imaging, SD was defined as a decrease in the sum of the largest diameters of the target lesions that did not reach PR or an increase in the size of the largest diameters of target lesions that did not reach PD. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, SD refers to a decrease of \>30% in the peak SUV.
Partial Metabolic Response (PMR)
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, PMR refers to a reduction in SUV of ≥15%-25% after one cycle of treatment and a reduction in SUV of \>25% after greater than one cycle of treatment.
Stable Metabolic Disease (SMD)
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, SMD refers to an increase in SUV of \<25% or a decrease of \<15%, and tumor no significant increase in the extent of uptake (\>20% increase in maximum diameter)
Pathologic Response
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
According to pathological efficacy assessment criteria, Pathological Complete Remission(pCR) refers to no detectable tumor (pT0) or residual cancer confined to the original site (pTis) after treatment. According to pathological efficacy assessment criteria, A decrease in tumor stage from cT2 (Muscle-Invasive Bladder Cancer - MIBC) to non-muscle-invasive bladder cancer (NMIBC), including stages pT0, pTis, pTa, and pT1, indicates a treatment-sensitive tumor and is considered a good pathologic response. Conversely, if the tumor stage remains the same or increases, it is considered a poor pathologic response.
Complete Remission (CR)
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
In RECIST 1.1 Efficacy assessment criteria for conventional imaging, CR was defined as the disappearance of all target lesions, the absence of new lesions, and the normalization of tumor markers for at least 4 weeks. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, CR refers to the complete disappearance of tracer uptake.
Complete Metabolic Response (CMR)
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, CMR refers to the complete disappearance of tracer uptake.
Progressive Metabolic Disease (PMD)
时间窗: Within 1 month after obtaining the surgical pathology report and imaging report results
For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, PMD refers to an increase in SUV value of \>25% and a significant increase in the extent of tumor uptake (increase in the largest diameter of \>20%), or the appearance of new foci.
次要结局
- Overall Remission Rate (Objective Response Rate, ORR)(Within 1 month after obtaining the surgical pathology report and imaging report results)
- Radiographic Progression Free Survival (rPFS)(1 years to 3 years after receiving treatment)
- Overall Survival (OS)(1 years to 3 years after receiving treatment)
- Disease Control Rate (DCR)(Within 1 month after obtaining the surgical pathology report and imaging report results)
研究者
Ning Xu
Deputy Director of Department
First Affiliated Hospital of Fujian Medical University