NCT01771497已完成不适用
Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Tumor volume change from baseline during neoadjuvant treatment
研究概览
简要总结
The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Female gender
- •Age 18 years or older
- •Any ethnicity
- •Are undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy
- •Is able to provide informed consent.
排除标准
- •Pregnancy
- •Lactation
- •Women who are unable or unwilling to understand or to provide informed consent
- •Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- •Women who are unable to tolerate study constraints.
- •Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to):
- •Treatment for enlarged thymus gland as an infant
- •Irradiation for benign breast conditions, including breast inflammation after giving birth
- •Treatment for Hodgkin's disease
- •Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- •Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to):
- •Tuberculosis
- •Severe scoliosis
结局指标
主要结局
Tumor volume change from baseline during neoadjuvant treatment
时间窗: Baseline, mid-point (~3 months), and end of therapy (4-6 months)
Tumor volume will be measured with KBCT imaging at the beginning of the therapy (baseline), mid-point of the therapy (about 3 months after the treatment starts) and end of therapy (about 4-6 months after the treatment starts). The volume change from the baseline during the treatment will be recorded. Adverse Events will be recorded as a measure of safety.
次要结局
未报告次要终点
研究者
研究点 (1)
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