Mapping of Lymph Nodes Using Augmented-reality/Virtual-reality Goggles in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient-level rate of clinically significant events (CSE)
研究概览
简要总结
This study tests whether special imaging goggles can help surgeons find lymph nodes that may be left behind during breast cancer surgery. The goggles show a fluorescent dye (indocyanine green, ICG) that is given during the operation and collects in lymph nodes.
In breast cancer surgery, the surgeon removes lymph nodes from the armpit (axilla) to check whether the cancer has spread. Some nodes can be difficult to see and may remain after the surgeon believes the removal is complete. This study looks at whether the goggles can reveal such remaining nodes after the surgeon has declared the axillary surgery finished.
Thirty patients having breast cancer surgery with removal of the axillary lymph nodes will take part. After the surgeon states the planned removal is complete, the surgeon will briefly re-examine the area using the goggles and the ICG signal. If additional glowing tissue is seen, the surgeon will decide-using normal surgical judgment-whether it is safe and appropriate to remove it. Any tissue removed this way is examined under the microscope to determine whether it is a lymph node and whether it contains cancer.
The study measures how often this additional examination finds cancer-containing nodes that would otherwise have remained, where these nodes are located, whether the finding changes the cancer stage, and how much extra time the examination takes. The study also records any side effects. The results will help determine whether this approach should be studied in a larger trial.
详细描述
Accurate axillary nodal staging is central to breast cancer management. During axillary lymph node dissection, some nodal tissue-particularly in the apical/high axilla-can remain after the operating surgeon considers the dissection complete. Near-infrared fluorescence imaging with indocyanine green (ICG) can highlight nodal tissue intraoperatively. This pilot evaluates a wearable augmented-reality imaging system that displays combined color and near-infrared information, used for a brief "second-look" examination after the surgeon has declared the axillary procedure complete.
This is a prospective, single-arm pilot in patients undergoing breast cancer surgery with complete axillary lymph node dissection. After the surgeon prospectively declares the axillary procedure complete, a short additional in vivo fluorescence review of the surgical field is performed. If additional fluorescent tissue is identified, it is re-assessed under standard operating-room lighting and removed only if the surgeon judges removal safe and clinically appropriate; goggle findings do not replace standard surgical judgment. Any tissue removed at the second-look is submitted separately for histopathology, and findings are classified by tissue type and anatomic location.
The study is exploratory and is not powered to demonstrate clinical benefit; it is intended to assess feasibility, safety, and an initial clinical signal to inform a larger study.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven breast cancer
- •Age 18 years or older
- •Undergoing radical surgery (mastectomy or quadrantectomy) with complete axillary lymph node dissection
- •Provides written informed consent
排除标准
- •Pregnancy
- •Neoadjuvant chemotherapy
- •Prior breast surgery
- •Iodine or seafood allergy
- •Indocyanine green (ICG) allergy
- •Declines or is unable to provide informed consent
结局指标
主要结局
Patient-level rate of clinically significant events (CSE)
时间窗: From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)
Proportion of patients with at least one clinically significant event (CSE). A CSE is defined as additional fluorescent tissue identified at the second-look review after the surgeon's declared completion of the axillary dissection, not previously planned for removal, removed after re-assessment under standard lighting, and confirmed on final histopathology to be a lymph node containing tumor (isolated tumor cells, micrometastasis, or macrometastasis).
次要结局
- Distribution of additional fluorescent findings by tissue category(Final histopathology (up to approximately 2 weeks after surgery))
- Anatomic location of additional fluorescent findings(Intraoperative (day of surgery))
- Nodal stage migration(Final histopathology (up to approximately 2 weeks after surgery))
- Added operative time for the second-look review(Intraoperative (day of surgery))
- Procedure- or device-related adverse events(Through 30 days after surgery)
研究者
Borislav Kondov
Professor / Principal Investigator
Ss. Cyril and Methodius University of Skopje