Imaging of In Vivo Sigma-2 Receptor Expression With [18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)
研究概览
简要总结
In this study, positron emission tomography (PET/CT) imaging will be used to evaluate sigma-2 (σ2) receptor activity in sites of primary breast cancer using the investigational radiotracer [18F]ISO-1.
详细描述
This study will evaluate the feasibility of using [18F]ISO-1 PET/CT to image sigma-2 receptor binding in primary breast tumors and continue to evaluate the safety of the tracer in this patient population. [18F]ISO-1 uptake measures will be correlated with qualitative immunohistochemical staining for cell proliferation (Ki67). This is an observational study in that [18F]ISO-1 PET/CT will not be used to direct treatment decisions.
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
- •Adult patients, at least 18 years of age
- •Known or suspected breast cancer with at least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI)
- •Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
排除标准
- •Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening.
- •Inability to tolerate imaging procedure in the opinion of an investigator or treating physician
- •Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- •Unwilling or unable to provide informed consent.
研究组 & 干预措施
ISO-1 PET/CT
All subjects will receive an [18F]ISO-1 PET/CT scan
干预措施: [18F]ISO-1 (Drug)
结局指标
主要结局
Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)
时间窗: 6 years
Correlate \[18F\]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)
次要结局
- Evaluate the feasibility of using [18F]ISO-1 to image sigma-2 receptor binding in breast cancer(6 years)
- Evaluate the safety of [18F]ISO-1(6 years)
- Correlate [18F]ISO-1 uptake with Autoradiography(6 years)
- Correlate [18F]ISO-1 uptake a with multi-gene expression assay, validated to predict recurrence(6 years)
- Correlate [18F]ISO-1 uptake with outcomes (e.g. time to recurrence, progression free survival and overall survival)(6 years)
- Test the association of [18F]ISO-1 uptake with phenotypic breast cancer subtypes (e.g. HER2+, TN, ER/PR+, etc.)(6 years)