Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities
研究概览
简要总结
The goal of this research study is to evaluate the performance of two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to assess whether findings from the combination or each individual test can assist radiologists in visualizing and characterizing beast abnormalities.
Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses a low dose of injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.
If PEM and/or Liquid Biopsy provide accurate information to assist radiologists in visualizing and characterizing breast abnormalities, this method may serve as the first step towards establishing these genomic and new imaging technologies as new diagnostic modalities and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Individuals who are older than 18 years of age
- •Individuals who are planned to undergo an MRI-guided biopsy based on high- risk screening imaging detected lesions
- •Individuals with the ability to understand and the willingness to sign a written informed consent document
排除标准
- •High-risk Individuals with screening-imaging studies without suspicious lesions detected by the standard of care mammogram and/or MRI
- •Individuals who are pregnant or who think they may be pregnant
- •Individuals who are breast-feeding
- •Individuals with known allergies to F-18 FDG
研究组 & 干预措施
Liquid Biopsy and Positron Emission Mammography (PEM)
To perform the Liquid Biopsy assays, a baseline blood sample will be collected prior to the MRI-guided biopsy, and a follow-up blood and a tissue sample (if available) may be requested post-surgery If malignancy is confirmed by the standard of care histopathology results.
To perform the Positron Emission Mammography (PEM), participants will be injected with 74 megabecquerel (MBq) of commercially distributed 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (F-18 FDG). Following a delay of one hour for F-18 FDG uptake, the study participants will undergo a bilateral 4-view combination PEM scan.
干预措施: Liquid Biopsy (Genetic)
Liquid Biopsy and Positron Emission Mammography (PEM)
To perform the Liquid Biopsy assays, a baseline blood sample will be collected prior to the MRI-guided biopsy, and a follow-up blood and a tissue sample (if available) may be requested post-surgery If malignancy is confirmed by the standard of care histopathology results.
To perform the Positron Emission Mammography (PEM), participants will be injected with 74 megabecquerel (MBq) of commercially distributed 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (F-18 FDG). Following a delay of one hour for F-18 FDG uptake, the study participants will undergo a bilateral 4-view combination PEM scan.
干预措施: Positron Emission Mammography (PEM) (Device)
结局指标
主要结局
Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities
时间窗: 3 years
The performance of PEM and/or Liquid Biopsy, including percent sensitivity, specificity, positive and negative predictive values, in visualization and characterization of suspicious breast abnormalities will be evaluated and compared to magnetic resonance imaging (MRI), and digital mammography.
次要结局
未报告次要终点