A Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Ultrasound detectability
研究概览
简要总结
Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.
详细描述
Nonrandomized clinical trial to evaluate the Mayo-designed marker for ultrasound conspicuity at the time of preoperative ultrasound-guided localization.
Study participants are breast cancer patients with pathology-proven metastatic axillary lymph nodes. Per standard of care, a biopsy marker will have already been associated with the positive lymph node. 10 such patients scheduled for surgery at Mayo Clinic Rochester, MN with Dr. James Jakub will be enrolled. Preoperative radioactive seed localization will proceed as usual, but the marker will be additionally loaded with the seed into the needle using standard protocol. Before surgery, ultrasound will be performed to evaluate the marker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- •Surgical management involves preoperative radioactive seed localization of a previously identified positive axillary lymph node
- •Surgery will be performed by Dr. James Jakub at Mayo Clinic Rochester, MN
- •Radioactive seed localization of an axillary lymph node.
- •No contraception is necessary or required.
- •English speaking
排除标准
- •Scheduled for only radioactive seed localizations in the breast (as opposed to axilla)
- •Are pregnant; although the twinkling marker is made of material widely used in orthopedic procedures, and hence, has an excellent safety profile, the investigators want to exclude the population of pregnant patients in this phase 0 clinical trial.
研究组 & 干预措施
Marking cN+ nodes
These patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed.
干预措施: Research Marker (Device)
结局指标
主要结局
Ultrasound detectability
时间窗: Time of placement to surgical resection.
Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.
次要结局
- Conspicuity compared to conventional biopsy markers and radioactive seeds(Time of placement to surgical resection.)
研究者
Christine U. Lee
Principal Investigator
Mayo Clinic