18F-FDG versus 68Ga-FAPI-46 as PET tracer in ER-positive breast cancer - a pilot study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine essential input parameters for an adequate sample size calculation for a diagnostic study that compares the diagnostic accuracy of 18F-FDG and 68Ga-FAPI-46 as PET tracer in patients with ER+ breast cancer.
研究概览
简要总结
The aim of this pilot study is to determine essential input parameters for an adequate sample size calculation for a diagnostic study that compares the diagnostic accuracy of 18F-FDG and 68Ga-FAPI-46 as PET-tracer in patients with ER+ breast cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient with histopathologically proven ER+ breast cancer.
- •Diagnosed with locally advanced (primary tumor >5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.
- •Willing and able to undergo the study procedures.
- •Has personally provided written informed consent.
排除标准
- •Pregnancy
- •Patients with secondary malignancies (except non-melanoma skin cancer)
- •No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.
- •Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity
- •Chronic inflammatory disease such as rheumatoid arthritis.
- •Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
- •Inability to provide informed consent.
结局指标
主要结局
To determine essential input parameters for an adequate sample size calculation for a diagnostic study that compares the diagnostic accuracy of 18F-FDG and 68Ga-FAPI-46 as PET tracer in patients with ER+ breast cancer.
时间窗: Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.
To investigate the proportion of discordant pairs: the number of lesions detected on 18F-FDG PET but not on 68Ga-FAPI-46 PET and the number of lesions detected on 68Ga-FAPI-46 PET but not on 18F-FDG PET.
次要结局
- To explore the feasibility of taking biopsies in test-positive patients.(Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.)
研究者
T.J.A. van Nijnatten
Scientific
University Hospital Maastricht