FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer

Not Applicable

Not yet recruiting

• Conditions: Urinary Bladder Neoplasms

• Registration Number: NCT06421142
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief 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.

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 Timeline

• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-24
• Study Start: 2024-07-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Inclusion criteria for MIBC diagnostic studies

  1. Patients with suspected muscle-invasive bladder cancer;
  2. Completion of FAPI PET/MRI, FDG PET/MRI and MRI;
  3. Complete clinical laboratory and pathological data.

• Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study

  1. Patients diagnosed with muscle invasive bladder cancer;
  2. Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy;
  3. Complete clinical laboratory and pathological data.

Exclusion Criteria

• Exclusion criteria for MIBC diagnostic study

  1. Combined with other malignant tumors;
  2. Not receiving surgical treatment;
  3. Receiving neoadjuvant therapy before surgery;
  4. Previous allergy to contrast components or similar components;
  5. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities;
  6. Incomplete clinicopathological data

• Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study

  1. Combination of other malignant tumors;
  2. FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy;
  3. Prior hypersensitivity to contrast components or similar components;
  4. Serious organ function abnormalities, such as serious abnormalities of heart, lung, liver and kidney function;
  5. Incomplete clinicopathological data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Negative Likelihood Ratio (NLR)	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	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)	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Remission Rate (Objective Response Rate, ORR)	Within 1 month after obtaining the surgical pathology report and imaging report results	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;
Radiographic Progression Free Survival (rPFS)	1 years to 3 years after receiving treatment	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 Survival (OS)	1 years to 3 years after receiving treatment	the duration from the time a patient receives systemic therapy to the time of death from any cause.
Disease Control Rate (DCR)	Within 1 month after obtaining the surgical pathology report and imaging report results	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.

Trial Locations

Locations (1)

first hospital affiliated of Fujian medical university; 🇨🇳 Fuzhou, Fujian, China