Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Maximum standardised uptake value [SUVmax] for primary lesion
研究概览
简要总结
The aim of this study is to compare the diagnostic performance of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT in primary and metastatic lesions of breast cancer and to reveal the best diagnostic imaging time of 68Ga-FAPI-46 PET/CT.
详细描述
Participants with breast carcinoma will undergo contemporaneous 18F-FDG and 68Ga-FAPI PET/CT. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT will be calculated and compared to evaluate the diagnostic efficacy. In addition, best diagnostic imaging time of 68Ga-FAPI-46 PET/CT will be evaluated at 10th, 30th and 60th minute scan time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult participants (aged 18 years or order);
- •participants with newly diagnosed breast carcinoma;
- •pathology confirmed by lesion tru-cut biopsy;
- •participants who were able to provide informed consent.
排除标准
- •participants with non-malignant lesions;
- •participants with pregnancy;
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
结局指标
主要结局
Maximum standardised uptake value [SUVmax] for primary lesion
时间窗: 2-3 days
SUVmax of 68Ga-FAPI PET/CT for breast carcinoma in comparison with SUVmax value of 18F-FDG PET/CT
Best diagnostic imaging time of 68GaFAPI-46 PET/CT
时间窗: 2-3 days
Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time
次要结局
- SUVmax for metastatic lymph nodes(2 days)
- Correlation between tumor SUVmax values and pathology grade(2 days)
- Diagnostic efficacy for breast carcinomas(2 days)
- Diagnostic efficacy for metastatic lymph nodes(2 days)
研究者
Fuad Novruzov
Head of Nuclear Medicine Department
The National Center of Oncology, Azerbaijan