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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIBC diagnostic study-FAPI PET/MRI | Experimental | suspected MIBC participants receive FAPI PET/MRI examination after entering the group. |
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| MIBC diagnostic study-FDG PET/MRI | Experimental | suspected MIBC participants receive FDG PET/MRI examination after entering the group. |
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| MIBC diagnostic study-MRI | Active Comparator | suspected MIBC participants receive MRI examination after entering the group. |
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| MIBC neoadjuvant evaluation study-FAPI PET/MRI | Experimental | Patients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy. |
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| MIBC neoadjuvant evaluation study-FDG PET/MRI | Experimental | Patients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 1 week after obtaining the surgical pathology report and imaging report results |
| 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. | Within 1 week after obtaining the surgical pathology report and imaging report results |
| 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%. | Within 1 week after obtaining the surgical pathology report and imaging report results |
| 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%. | Within 1 week after obtaining the surgical pathology report and imaging report results |
| Positive Likelihood Ratio (PLR) | 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%. | Within 1 week after obtaining the surgical pathology report and imaging report results |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | the duration from the time a patient receives systemic therapy to the time of death from any cause. | 1 years to 3 years after receiving treatment |
| Radiographic Progression Free Survival (rPFS) |
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Inclusion Criteria:
Inclusion criteria for MIBC diagnostic studies
Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study
Exclusion Criteria:
Exclusion criteria for MIBC diagnostic study
Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Xu, Doctor | Contact | 13235907575 | 0086 | drxun@fjmu.edu.cn |
| Xiao-Dong Li, Master | Contact | 15980273075 | 0086 | lixiaodong@fjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xue-Yi Xue, Master | First Affiliated Hospital of Fujian Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| first hospital affiliated of Fujian medical university | Recruiting | Fuzhou | Fujian | 350005 | China |
We have chosen not to share the individual participant data (IPD) from this clinical study due to privacy and confidentiality concerns, as well as potential proprietary interests. Additionally, sharing IPD requires considerable resources for data de-identification and preparation, which may not be feasible within the scope of this study. However, we remain committed to transparency and will provide summary results and findings through appropriate channels, ensuring the dissemination of key insights while safeguarding participant privacy and confidentiality
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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In the MIBC diagnostic study and neoadjuvant efficacy prediction study, each patient underwent FAPIPET/MRI, FDGPET/MRI and MRI examinations, and were grouped and analyzed according to different examination methods.
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| MIBC neoadjuvant evaluation study-MRI | Active Comparator | Patients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy. |
|
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| Negative Likelihood Ratio (NLR) |
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%. |
| Within 1 week after obtaining the surgical pathology report and imaging report results |
| Youden Index | 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) | Within 1 week after obtaining the surgical pathology report and imaging report results |
| Standardized uptake values peak, maximum, and mean (SUVpeak , SUVmax, SUVmean) | changes in SUVmax, SUVmean, and SUVpeak of the tumor lesion before and after treatment obtained from PET/MRI images. | Within 1 week after obtaining the surgical pathology report and imaging report results |
| Tumor-to-Background Ratio (TBR) | 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. | Within 1 week after obtaining the surgical pathology report and imaging report results |
| Complete Remission (CR) | 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
| Partial Remission (PR) | 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
| Stable Disease (SD) | 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
| Progressive Disease (PR) | 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
| Complete Metabolic Response (CMR) | 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
| Partial Metabolic Response (PMR) | 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
| Stable Metabolic Disease (SMD) | 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) | Within 1 month after obtaining the surgical pathology report and imaging report results |
| Progressive Metabolic Disease (PMD) | 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
| Pathologic Response | 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
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.
| 1 years to 3 years after receiving treatment |
| 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; | Within 1 month after obtaining the surgical pathology report and imaging report results |
| 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. | Within 1 month after obtaining the surgical pathology report and imaging report results |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |