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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Diagnostic Sensitivity [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Diagnostic Specificity [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Positive Expected Value (PPV) [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Negative Expected Value (NPV) [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Positive Likelihood Ratio (PLR) [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Negative Likelihood Ratio (NLR) [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Youden Index [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Standardized uptake values peak, maximum, and mean (SUVpeak , SUVmax, SUVmean) [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Tumor-to-Background Ratio (TBR) [Срок оценки: Within 1 week after obtaining the surgical pathology report and imaging report results]
• Complete Remission (CR) [Срок оценки: Within 1 month after obtaining the surgical pathology report and imaging report results]

Вторичные конечные точки (4)

• Overall Survival (OS) [Срок оценки: 1 years to 3 years after receiving treatment]
• Radiographic Progression Free Survival (rPFS) [Срок оценки: 1 years to 3 years after receiving treatment]
• Overall Remission Rate (Objective Response Rate, ORR) [Срок оценки: Within 1 month after obtaining the surgical pathology report and imaging report results]
• Disease Control Rate (DCR) [Срок оценки: Within 1 month after obtaining the surgical pathology report and imaging report results]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• first hospital affiliated of Fujian medical university — Фучжоу

Идентификаторы

NCT: NCT06421142 · 2024-041-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗