ACTRN12621000126819招募中1 期
A Phase I Study Investigating the Safety and Efficacy of the MagSense (Trademark) Human Epidermal Growth Factor Receptor 2 (HER2) Test Reagent Using Magnetic Resonance Imaging and the MagSense (Trademark) Instrument in Subjects with HER2-positive Breast Cancer to Test for Ipsilateral Lymph Node Involvement
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •To be eligible for study entry subjects must satisfy all of the following criteria
- •* Female subjects
- •* Written informed consent provided for participation in the study;
- •* In the opinion of investigator, willing and able to comply with required study procedures;
- •* Histologically confirmed HER2-positive primary breast cancer;
- •* No prior treatment for breast cancer including surgery, radiotherapy, or systemic treatment;
- •* In the investigator’s judgment from previous clinical, pathological, or imaging evidence have a likelihood of having at least 1 lymph node metastasis;
- •* Scheduled for surgical intervention with a SLNB and/or ALND as guided by technetium-99m (99mTc) diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a node that is clinically suspicious, or have already had a lymph node biopsy and are willing to have a second core biopsy;
- •* A female subject who is not pregnant or breastfeeding,
排除标准
- •Subjects will be excluded from the study if 1 or more of the following criterion are applicable:
- •* Contraindications to the use of any aid in detecting nodes during surgery including other magnetic localisation systems or 99mTc-based diagnostic agents for those subjects scheduled for a SLNB and/or ALND;
- •* Known hypersensitivity to iron oxide or polyethylene glycol compounds;
- •* For those subjects scheduled for a SLNB and/or ALND, contraindications to the use of 99mTc diagnostic agents;
- •*Prior history of iron overload disease;
- •* Known clinical or radiological evidence of distant metastases (Stage IV disease);
- •* Known inflammatory breast cancer;
- •* Prior surgical axillary procedure including SLNB or ALND on the ipsilateral side of the breast cancer primary;
- •* Prior history of breast cancer;
- •* History of lymphoma with breast or axillary node involvement;
- •* Previous radiation to the ipsilateral breast or axilla;
- •* Known metal implant in the ipsilateral axilla or in the ipsilateral chest;
- •* Any contraindications to MRI imaging;
- •* Any implant anywhere in the body that produces a magnetic field;
- •* Recent history of ferumoxytol therapy in the past 6 months;
- •* Subject received an investigational agent (treatment or diagnostic) within 30 days prior to the surgery;
- •* Clinically significant acute illness within 4 weeks or other illness deemed to be significant by investigator with agreement of sponsor within 5 days before Day 1;
- •* Subject, in the opinion of the investigator, should not participate in the study.
研究者
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