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Recruiting NCT06421142

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

No phase Interventional Urinary Bladder Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI.
Who it may be relevant to
Registry conditions: Urinary Bladder Neoplasms. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Diagnostic Sensitivity [Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results]
  • Diagnostic Specificity [Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results]
  • Positive Expected Value (PPV) [Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results]
  • Negative Expected Value (NPV) [Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results]
  • Positive Likelihood Ratio (PLR) [Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results]
  • Negative Likelihood Ratio (NLR) [Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results]
  • Youden Index [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) [Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results]
  • Tumor-to-Background Ratio (TBR) [Time frame: Within 1 week after obtaining the surgical pathology report and imaging report results]
  • Complete Remission (CR) [Time frame: Within 1 month after obtaining the surgical pathology report and imaging report results]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • Inclusion criteria for MIBC diagnostic studies
  • 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.

Exclusion criteria

  • Exclusion criteria for MIBC diagnostic study
  • 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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • first hospital affiliated of Fujian medical university — Fuzhou

Identifiers

NCT: NCT06421142 · 2024-041-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗