A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Identification
研究概览
简要总结
According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Stage I, II or III cancers. Breast conservation surgery has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast cancer are breast conservation candidates. However, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. Currently, tumor margins assessment in the operating room is often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 18 years of age
- •Women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates (i.e. lumpectomy +/- sentinel node biopsy).
- •Breast cancer needs to be unifocal as determined by clinical parameters, e.g. by palpation or by breast imaging findings including mammogram, US and/or breast MRI. Multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are deemed breast conservation candidates.
- •Subject capable of giving informed consent and participating in the process of consent.
排除标准
- •Newly diagnosed breast cancer patients who are not breast conservation candidates and those with multicentric breast cancer (breast cancer documented in multiple quadrants by breast imaging or exam)
- •Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
- •Subjects with a history of iodide allergies
- •At-risk patient populations
- •Homeless patients
- •Patients with drug or alcohol dependence
- •Patients unable to participate in the consent process
研究组 & 干预措施
IV Injection of ICG
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Identification
时间窗: After infusion of ICG
The primary outcome will be the proportion of patient's tumors identified by ICG uptake versus the proportion of patients identified by visual and tactile methods by the surgeon (considered standard of care)
次要结局
- Evaluation(0-5 years after surgery)