Clinical trial NCT06421142: FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Bladder Neoplasms
Keywords: Neoadjuvant Chemotherapy
Neoplasm Staging
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Sensitivity
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Diagnostic Specificity
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Positive Expected Value (PPV)
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Negative Expected Value (NPV)
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Positive Likelihood Ratio (PLR)
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Negative Likelihood Ratio (NLR)
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Youden Index
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Standardized uptake values peak, maximum, and mean (SUVpeak , SUVmax, SUVmean)
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Tumor-to-Background Ratio (TBR)
timeFrame: Within 1 week after obtaining the surgical pathology report and imaging report results
measure: Complete Remission (CR)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Partial Remission (PR)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Stable Disease (SD)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Progressive Disease (PR)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Complete Metabolic Response (CMR)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Partial Metabolic Response (PMR)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Stable Metabolic Disease (SMD)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Progressive Metabolic Disease (PMD)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Pathologic Response
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 1 years to 3 years after receiving treatment
measure: Radiographic Progression Free Survival (rPFS)
timeFrame: 1 years to 3 years after receiving treatment
measure: Overall Remission Rate (Objective Response Rate, ORR)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
measure: Disease Control Rate (DCR)
timeFrame: Within 1 month after obtaining the surgical pathology report and imaging report results
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: first hospital affiliated of Fujian medical university
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Xue-Yi Xue, Master
role: STUDY_CHAIR
References: