A Pilot Study Evaluating Quantitative Volume Contrast Enhanced Ultrasound (VCEUS) Imaging for Determining Early Breast Cancer Response to Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Tumor Volume Measure Using Grayscale US
研究概览
简要总结
- Evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale ultrasound and post-treatment mammography findings utilizing final surgical pathology and clinical outcome.
- Assess incremental benefit of quantitative VCEUS to planar CEUS tumor perfusion measurements and enhancement patterns in predicting tumor response to adjuvant treatment in clinical studies.
The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound (echocardiography) of the heart. Definity® will be used "off-label" (during ultrasound of the breast) in this study. The administration of Definity® during this study will follow total dose guidelines approved by the FDA.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age 19 years or older).
- •Patients with newly diagnosed and untreated stage II and III breast cancer scheduled to undergo neoadjuvant chemotherapy.
- •Patients with signed informed consent.
排除标准
- •Any history of prior radiation or chemotherapy for breast cancer.
- •Patients who only have non-measurable disease.
- •Patients who are medically unstable.
- •Patients with other primary cancers requiring systemic treatment.
- •Patients with cardiac shunts.
- •Patients with unstable cardiopulmonary conditions.
- •Patients with known pulmonary hypertension.
- •Patients with known hypersensitivity to any component of Definity (R) microbubble contrast.
- •Patients who are pregnant, breast-feeding or are planning to become pregnant during the study duration.
研究组 & 干预措施
2D US grayscale plus quantitative VCEUS
Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging followed by quantitative VCEUS imaging:
- prior to initiation of treatment (baseline);
- at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);
- at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);
- at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.
干预措施: 2D US grayscale plus quantitative VCEUS (Diagnostic Test)
结局指标
主要结局
Tumor Volume Measure Using Grayscale US
时间窗: 6 months
Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.
VCEUS Perfusion Time to Peak
时间窗: 6 months
Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.
次要结局
- Pathology Residual Tumor(6 months)
研究者
Mark E. Lockhart
Professor
University of Alabama at Birmingham