Sienna+® Injection Time Study: A Prospective Multicentre, Controlled Clinical Trial to Evaluate the Performance of Superparamagnetic Iron Oxide vs. Standard Technique as Tracer in Sentinel Node Biopsy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Detection rate per Patient
研究概览
简要总结
Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.
详细描述
Sienna+® is injected either 1 day or 4-6 days before surgery, either retro-mamillary or peri-tumorally:
- Sienna+® retro-mamillary 1 day before surgery: 10 patients
- Sienna+® peri-tumorally 1 day before surgery: 10 patients
- Sienna+® retro-mamillary 4-6 days before surgery: 10 patients
- Sienna+® peri-tumorally 4-6 days before surgery: 10 patients In each case, Technetium as standard technique is employed according to the gold standard protocol one day before surgery.
The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has a diagnosis of primary breast cancer
- •Subject has been scheduled for surgery with a sentinel lymph node biopsy procedure
- •Subject is ≥18 years old at time of consent
- •Subject has an ECOG performance status of Grade 0-2
- •Subject has a clinical negative node status
- •Subject is available for the follow-up
排除标准
- •Subject is pregnant or lactating
- •Subject has a radiological evidence of metastatic cancer
- •Subject has had previous axilla surgery or reduction mammoplasty
- •Subject has impaired lymphatic function
- •Subject has had a preoperative radiation therapy
- •Subject has iron overload disease or iron/dextran intolerance
- •Subject has a pacemaker
- •Subject is under guardianship
结局指标
主要结局
Detection rate per Patient
时间窗: During surgery
Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.
次要结局
- Nodal detection rate(During surgery)
- Number of lymph nodes excised(During surgery)
- Malignancy rate(1-2 days post surgery)
研究者
Nik Hauser
Director Department of Gynecology and Obstetrics
Kantonsspital Baden