JPRN-jRCTs042210020已完成未知
Study on the safety and usefulness of targeted axillary dissection using the Hydromark and Guiding Marker System after Neo-Adjuvant chemotherapy for breast cancer patients
Kotani Haruru0 个研究点目标入组 30 人开始时间: 2021年5月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
o adverse events were observed with the HydroMARK and Guiding-marker system, and the success rate of TAD was met in more than 90% of cases. Hence, we were able to demonstrate the usefulness of TAD with Guiding-marker system.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients pathologically diagnosed with breast cancer and axillary lymph node metastasis.
- •2. Clinically confirmed 1 to 3 axillary lymph node metastases
- •3. Histological type can be anything.
- •4. Patients planning to receive standard neoadjuvant chemotherapy for primary breast cancer
- •5. Age at the time of consent is 20 years or older
- •6. ECOG Performance Status (PS) of 0 to 2
- •7. Meet all of the following criteria for organ function (within 21 days before registration)
- •(1) Neutrophil count >=1,500/mm3 or WBC >= 3,000/mm3
- •(2)Hemoglobin >= 8.0g/dL
- •(3) Platelet count >= 100,000/mm3
- •(4)Total bilirubin is 1.5 times or less of the normal upper limit
- •(5)AST (GOT) and ALT (GPT) <=100U/L
- •(6)Serum creatinine is less than 1.5 times the upper limit of normal.
- •8. The diseased upper limb can be lifted in the supine position.
- •9. Patients who submits written consent herself after receiving sufficient explanation about this study
排除标准
- •1. Pregnant women, those with a positive pregnancy test, within 28 days after giving birth, or during lactation
- •2. Severe mental disease.
- •3. Patient who is assessed not applicable by investigator.
研究者
相似试验
已完成
不适用
Effectiveness and Safety Evaluation of Aqueduct -100 DeviceCervix Uteri DilationNCT02851953Aqueduct Medical Ltd41
已完成
不适用
Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology LensMyopiaNCT05984290Bausch & Lomb Incorporated90
Unknown
不适用
Impact on the Adverse Event (AE) Incidence of Two Types of Experience Feedback on AE Analyzed During Local Morbidity Mortality ReviewsHospital Adverse EventNCT02771613Hospices Civils de Lyon144,000
已完成
不适用
Clinical Investigation on the Use of Ophthalmic Solution Based on Sodium Hyaluronate in Treatment of Eye DiscomfortOcular DrynessNCT05777798SIFI SpA28
已完成
4 期
Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance SystemAccurate Navigation to the LesionNCT01367392ActiViews Ltd.20