An interventional study of imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI in Urinary Bladder Neoplasms, sponsored by First Affiliated Hospital of Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by First Affiliated Hospital of Fujian Medical University · Not applicable, Interventional, and Diagnostic
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.
1,617 studies on the registry are indexed under Urinary Bladder Neoplasms; 422 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →First Affiliated Hospital of Fujian Medical University is the lead sponsor of 92 studies on the registry; 55 are open to participants now.
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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
suspected MIBC participants receive FAPI PET/MRI examination after entering the group.
Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
suspected MIBC participants receive FDG PET/MRI examination after entering the group.
Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
suspected MIBC participants receive MRI examination after entering the group.
Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
Patients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy.
Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
Patients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy.
Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
Patients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy.
Procedure: imaging 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.
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.
Time frame: 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.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results
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%.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Within 1 month after obtaining the surgical pathology report and imaging report results
Overall Survival (OS)
the duration from the time a patient receives systemic therapy to the time of death from any cause.
Time frame: 1 years to 3 years after receiving treatment
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.
Time frame: 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;
Time frame: 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.
Time frame: Within 1 month after obtaining the surgical pathology report and imaging report results
Plan to share: No — 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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First Affiliated Hospital of Fujian Medical University