[Translation] A phase II, open-label, multicenter clinical trial evaluating the diagnostic efficacy of PET/MRI imaging with 18F-BR-02 injection in detecting brain metastases and recurrence in patients with solid tumors.
1. 主要目的:评价18F-BR-02注射液PET/MRI与使用大环钆造影剂的 MRI在实体瘤患者中检测系统性治疗后脑转移复发的一致性
2. 次要目的:1) 评估18F-BR-02注射液在实体瘤患者中检测脑转移复发的诊断效能 2)评估18F-BR-02注射液在实体瘤患者中检测脑转移复发的病灶水平的诊断效能 3)评估18F-BR-02注射液在实体瘤患者中检测脑转移复发的诊断性能 4)评估18F-BR-02注射液在实体瘤患者中的安全性
3. 探索性目的:分析18F-BR-02注射液PET/MRI在病灶摄取视觉判断的不同阈值水平,对患者水平和病灶水平的诊断效能的影响
[Translation] 1. Primary Objective: To evaluate the concordance between 18F-BR-02 injection PET/MRI and MRI using macrocyclic gadolinium contrast agents in detecting recurrent brain metastases after systemic therapy in patients with solid tumors.
2. Secondary Objectives:
1) To assess the diagnostic efficacy of 18F-BR-02 injection in detecting recurrent brain metastases in patients with solid tumors.
2) To assess the diagnostic efficacy of 18F-BR-02 injection in detecting lesion-level recurrent brain metastases in patients with solid tumors.
3) To assess the diagnostic performance of 18F-BR-02 injection in detecting recurrent brain metastases in patients with solid tumors.
4) To assess the safety of 18F-BR-02 injection in patients with solid tumors.
3. Exploratory Objective: To analyze the impact of different threshold levels for visual judgment of lesion uptake by 18F-BR-02 injection PET/MRI on the diagnostic efficacy at both the patient and lesion levels.