RENATA Study: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer and Prior Axillary Surgical Techniques and Approaches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Drainage pathways description
研究概览
简要总结
The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are:
- What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries?
- How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit?
Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team.
详细描述
Prospective multicentric collection will be conducted for all patients diagnosed with ipsilateral recurrent breast cancer, who meet the criteria and are eligible for surgery, and who wish to participate in the study. Additional examinations and treatments will be performed according to standard clinical practice. Tests not included in routine practice will not be conducted.
Suspicion of axillary involvement will be ruled out using ultrasound or magnetic resonance imaging, as well as distant metastasis with standard staging studies (bone scintigraphy/computed tomography of the thorax, abdomen, and pelvis).
Lymphatic mapping will be performed according to each hospital's protocol, similar to lymphatic mapping in primary breast cancer. The radiotracer/dye will be injected according to each center's standard practice (peritumoral, intratumoral, intradermal, or periareolar in the quadrant of the tumor) the day before or on the day of surgery by Nuclear Medicine/Radiology. Lymphoscintigraphy will be performed, and the detected sentinel lymph nodes (SLNs) will be marked on the skin with ink/marker. In cases where the SLN is not visualized, a second dose of radiotracer may be administered.
If there is no drainage from the SLN and no prior lymphadenectomy (LA), additional axillary surgery will not be performed. If there is no drainage from the SLN and no prior LA, consideration will be given to performing lymphadenectomy according to each center's protocol.
During surgery, SLNs will be identified using a gamma probe and/or dye, with assistance from the nuclear medicine service. Between one and three SLNs will be removed (whether drainage is in the ipsilateral axilla, internal mammary, or contralateral axilla). They will be sent to Pathology for intraoperative or deferred examination (by One-Step Nucleic Acid Amplification (OSNA) or conventional technique).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years old with ipsilateral local recurrence of breast cancer with clinical stage cT1-3 cN0 confirmed by histology, with a history of previous axillary surgery (both sentinel lymph node biopsy and lymphadenectomy).
排除标准
- •Patients with confirmed axillary metastasis (histology/immunohistochemistry)
- •Inflammatory carcinoma
- •Patients with suspected or confirmed distant metastasis on staging studies
- •Inability to perform the sentinel lymph node biopsy technique: allergy to radiotracer, mobility limitation
结局指标
主要结局
Drainage pathways description
时间窗: 12 months
Describe and study the drainage pathways including the ipsilateral axilla, the internal mammary chain, and the contralateral axilla
Re-Sentinel Lymph node harvesting rate
时间窗: 12 months
Calculation of SLN identification rate and analysis of subgroups based on previous axillary surgery.
次要结局
- Complications rate(12 months)
- Quality of life in recurrent breast cancer(12 months)
- Axillary metastasis rate(12 months)
- Correlation Between Axillary and Internal Mammary Chain Infiltration(12 months)