NCT03057743终止不适用
Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Pilot study using [18F]ISO-1 PET/CT to image sigma-2 receptor binding in metastatic breast cancer. Correlate baseline uptake and change in uptake after therapy with time to progression and standard and experimental pathology assays of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18 years, with at least one site of disease outside the liver by at least one type of standard imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •At least 18 years of age
- •Biopsy proven or clinically documented metastatic breast cancer with at least one lesion outside the liver by standard imaging (e.g. CT, MRI, Bone Scan, Ultrasound, FDG PET/CT)
- •Plan to start new systemic therapy for metastatic disease.
- •Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study 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.
结局指标
主要结局
Progression free survival
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
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