Urinary Bladder NeoplasmsNCT06421142
FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer
A study testing imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI in people with Urinary Bladder Neoplasms, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2024to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
first hospital affiliated of Fujian medical university
Fuzhou, Fujian, 350005
Xu Ning, M.D.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
- Keywords
- Neoadjuvant Chemotherapy, Neoplasm Staging
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| MIBC diagnostic study-FAPI PET/MRI | Experimental | suspected MIBC participants receive FAPI PET/MRI examination after entering the group. Receives: Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI |
| MIBC diagnostic study-FDG PET/MRI | Experimental | suspected MIBC participants receive FDG PET/MRI examination after entering the group. Receives: Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI |
| MIBC diagnostic study-MRI | Active comparator | suspected MIBC participants receive MRI examination after entering the group. Receives: Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI |
| MIBC neoadjuvant evaluation study-FAPI PET/MRI | Experimental | Patients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy. Receives: Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI |
| MIBC neoadjuvant evaluation study-FDG PET/MRI | Experimental | Patients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy. Receives: Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI |
| MIBC neoadjuvant evaluation study-MRI | Active comparator | Patients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy. Receives: Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Within 1 month after obtaining the surgical pathology report and imaging report results
Secondary outcomes (4)
Overall Survival (OS)
the duration from the time a patient receives systemic therapy to the time of death from any cause.
Measured: 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.
Measured: 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;
Measured: 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.
Measured: Within 1 month after obtaining the surgical pathology report and imaging report results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start2 Aug 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Xu, First Affiliated Hospital of Fujian Medical University
- Investigators
- Xue-Yi Xue, Master, Study chair, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421142
- Sponsor's protocol ID
- 2024-041-02
- Status last verified
- May 2026
- First submitted
- 9 May 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06421142
- Acronym / sponsor ID
- 2024-041-02
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Neoadjuvant Chemotherapy, Neoplasm Staging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MIBC diagnostic study-FAPI PET/MRI | Experimental | Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRIsuspected MIBC participants receive FAPI PET/MRI examination after entering the group. |
| MIBC diagnostic study-FDG PET/MRI | Experimental | Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRIsuspected MIBC participants receive FDG PET/MRI examination after entering the group. |
| MIBC diagnostic study-MRI | Active comparator | Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRIsuspected MIBC participants receive MRI examination after entering the group. |
| MIBC neoadjuvant evaluation study-FAPI PET/MRI | Experimental | Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRIPatients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy. |
| MIBC neoadjuvant evaluation study-FDG PET/MRI | Experimental | Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRIPatients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy. |
| MIBC neoadjuvant evaluation study-MRI | Active comparator | Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRIPatients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study
Key exclusion criteria (12 listed)
- Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRIFAPI 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. | Procedure or surgery | MIBC diagnostic study-FAPI PET/MRI, MIBC diagnostic study-FDG PET/MRI, MIBC diagnostic study-MRI, MIBC neoadjuvant evaluation study-FAPI PET/MRI, MIBC neoadjuvant evaluation study-FDG PET/MRI, MIBC neoadjuvant evaluation study-MRI |
Primary outcome
Diagnostic Sensitivity
Time frame: 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
Time frame: 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)
Time frame: 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%.
Negative Expected Value (NPV)
Time frame: 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%.
Positive Likelihood Ratio (PLR)
Time frame: 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%.
Negative Likelihood Ratio (NLR)
Time frame: 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
Time frame: 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)
Standardized uptake values peak, maximum, and mean (SUVpeak , SUVmax, SUVmean)
Time frame: 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.
Tumor-to-Background Ratio (TBR)
Time frame: 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.
Complete Remission (CR)
Time frame: 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.
Partial Remission (PR)
Time frame: 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.
Stable Disease (SD)
Time frame: 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.
Progressive Disease (PR)
Time frame: 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.
Complete Metabolic Response (CMR)
Time frame: 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.
Partial Metabolic Response (PMR)
Time frame: 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)
Time frame: 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)
Progressive Metabolic Disease (PMD)
Time frame: 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.
Pathologic Response
Time frame: 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.
4 secondary outcomes
Overall Survival (OS)
Time frame: 1 years to 3 years after receiving treatment
Radiographic Progression Free Survival (rPFS)
Time frame: 1 years to 3 years after receiving treatment
Overall Remission Rate (Objective Response Rate, ORR)
Time frame: Within 1 month after obtaining the surgical pathology report and imaging report results
Disease Control Rate (DCR)
Time frame: Within 1 month after obtaining the surgical pathology report and imaging report results
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xue-Yi Xue, Master study chair
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI in people with Urinary Bladder Neoplasms, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Xu, Doctor (13235907575 ext. 0086, drxun@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity (time frame: Within 1 week after obtaining the surgical pathology report and imaging report results). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.