NCT01790399Unknown不适用
IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 115
- 试验地点
- 8
- 主要终点
- Sentinel node(s)detected with new technical
研究概览
简要总结
The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study
详细描述
- Identification of Sentinel node(s)
- Step 1: Identification using the technique Nanocis Sub-areolar injection of Tc99m-Nanocis ® the day before or the day of surgery
- Step 2: Identification using the technique SentiMag ® / Sienna+ Injection Sienna + ™ should be done just after induction of anesthesia and before the injection of Patent Blue dye
- Step 3: Identification using the technique of Patent Blue Dye or Lymphotropic dye injection or Patent Blue is performed after induction of anesthesia, the injection and production Sienna + ™, the operating theater by the surgeon
- Detection of Sentinel node(s)
- Step 1: probe SentiMag ® (study)
- Step 2: hand probe gamma radiation detection and / or colorimetric detection (standard)
- Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown)
- After the procedure:
Characterization of the size and weight of lymph nodes, histological and / or molecular OSNA and linking nodal status with the detection rate of sentinel nodes for each technique.
NB: In case of synchronous bilateral cancer, 2 records are possible
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
- •Patient with invasive breast cancer or microinfiltrant proven by cytology and histo-or whatever the histological type
- •cT0/cT1/cT2 (up to 5 cm) CN0 clinical and / or ultrasound and without prior treatment (chemotherapy or neoadjuvant hormone )
- •Age greater than or equal to 18
- •Reporting of breast surgery and axillary staging of sentinel lymph node
- •Using effective contraception (BHCG negative)
- •Patient affiliated with a health insurance
- •Consent signed by the patient
排除标准
- •T3 or T4 tumors (> 5 cm, cutaneous or muscle inflammation or cancer)
- •Presence of a clinically suspicious axillary adenopathy or imaging
- •Tumors bifocal or multifocal known before Surgery
- •History of breast surgery or axillary
- •Patient metastatic
- •Patient with a cons-indication anesthesia and / or surgery
- •Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to Patent blue dye in centers where it is commonly used
- •Patient can not receive a radioactive isotope to the sentinel lymph node resection
- •Allergy radioactive product
- •Chronic iron overload
- •Pacemaker or other implantable device in the chest wall
- •Failure to submit to medical study for geographical, social or psychological
- •Patient deprived of liberty or under guardianship
- •Pregnant or lactating
结局指标
主要结局
Sentinel node(s)detected with new technical
时间窗: The day of surgery
Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)
次要结局
- Detected node(s) for each method(standard and new)(The day of surgery)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
GROningen INternational Study on Sentinel nodes in Vulvar cancer. An observational study.Squamous cell carcinoma of the vulvaNL-OMON23376Dutch Cancer Society (KWF Kankerbestrijding)1,500
已完成
不适用
Magseed and Magtrace Localization for Breast CancerBreast CarcinomaBreast Carcinoma Metastatic in Lymph NodeNCT05161507University Hospital Ostrava70
终止
不适用
Feasibility of Sentinel Lymph Node Biopsy in Rectal CancerRectal CancerNCT02445456Oxford University Hospitals NHS Trust15
已完成
1 期
Detection of sentinel lymph node using contrast-enhanced ultrasonographyOral cancer and Oropharyngeal cancerOther cancerJPRN-jRCTs041180002WAKISAKA Naohiro2
已完成
不适用
SentiMag® Intraoperative Comparison in Breast CancerBreast CancerNCT02336737Endomagnetics Inc160