Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- area under the curve (AUC)
研究概览
简要总结
Blood perfusion insufficiency and hypoxia are the main causes of drug resistance to chemotherapy in breast cancer. Increasing blood perfusion can improve drug delivery. The cavitation effect of ultrasound-stimulated microbubbles (USMBs) is known to enhance tumor blood perfusion, so we conducted a prospective human study to investigate the effects of USMBs on hemoperfusion in invasive breast cancer (IBC).
详细描述
patients with IBC were selected from the breast surgery department of our hospital. To induce an enhanced perfusion effect, IBC tumors were treated with SonoVue® microbubbles (MBs) stimulated by ultrasound, with a mechanical index (MI) of 0.2-0.3; 1 mL of SonoVue® MBs were injected at 3.5-min intervals three times for a USMB treatment lasting 10 min. The contrast-enhanced ultrasound (CEUS) parameters peak intensity (PI), area under the curve (AUC), and perfusion area were used to evaluate the changes in blood perfusion.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Invasive Breast Cancer
- •patients scheduled to undergo surgical resection
- •maximum lesion diameter < 4 cm
- •age over 18 years
排除标准
- •patients with allergies to SonoVue®
- •patients with severe cardiopulmonary insufficiency,
- •patients who had already received neoadjuvant chemotherapy
- •pregnant women
- •individuals with mental illness
- •Patients who refused to participate in the study
结局指标
主要结局
area under the curve (AUC)
时间窗: 15 minutes after the USMB procedure
AUC represents the total amount of MB passing through the ROI during perfusion; thus, a larger AUC corresponds to greater perfusion in the ROI.
changes in peak intensity (PI)
时间窗: 15 minutes after the USMB procedure
PI represents the quantitative scale of the highest average concentration of microbubble (MB) in the region of interest (ROI); thus, a larger PI corresponds to a higher concentration of MB in the ROI.
percentage increase in the perfusion area (%) of tumor
时间窗: 15 minutes after the USMB procedure
The percentage increase in the perfusion area (%) was calculated as follows: (perfusion area after the USMB procedure - perfusion area before the USMB procedure) × 100%/perfusion area before the USMB procedure. The greater "percentage increase of perfusion area (%)", the more significant the improvement of blood perfusion.
次要结局
未报告次要终点