ACTRN12621000687897终止未知
Magnetic Sentinel Lymph Node Mapping with FerroTrace in Breast Cancer: A Feasibility and Validity Clinical Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 2
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 75 Years（—）
- 性别
- Female
入选标准
- •1.Subject is capable of understanding, and willing to provide, written informed consent.
- •2.Female between 18 and 75 years of age (inclusive) at the time of providing informed consent.
- •3.Subject with a confirmed diagnosis of primary breast cancer.
- •4.Subject is scheduled for lumpectomy and an SLNB procedure as part of the surgical plan.
- •5.Subject has a clinical negative node status (i.e., cN0) at the time of providing informed consent.
- •6.Pre-menopausal subjects must be willing to use methods of contraception as deemed adequate by the Investigator to be eligible for, and continue participation in, the study.
- •7.Subject has had contrast-enhanced mammography showing no, minimal, or mild background parenchymal enhancement.
- •8.In the opinion of the Investigator, the subject can complete the study in compliance with the protocol and is able to comply with the requirements of the study protocol.
- •9.Subjects with an ECOG performance status of Grade 0–2.
排除标准
- •1. Subject has had preoperative radiation therapy to the affected breast or axilla.
- •2.Subject has received a Feraheme® (ferumoxytol) injection within the past 180 days.
- •3.Subject has a known history of allergies, hypersensitivity, or intolerances as follows:
- •a.Iron compounds
- •b.Polyacrylamide
- •d.Known or suspected hypersensitivity to the investigational product, or to any ingredients of the investigational product.
- •4.Subject known to have haemochromatosis
- •5.Subject has a co-morbid condition with an estimated life expectancy of <180 days at the time of consent.
- •6.Subjects who are pregnant, trying to fall pregnant in prior 14 days, or lactating at time of screening.
- •7.Subject has participated in another investigational drug study within 30 days of scheduled surgery.
- •8.Subject has one or more absolute contraindications to MRI scanning as per Investigator judgement.
- •9.Subject has had contrast-enhanced mammography showing moderate or marked background parenchymal enhancement.
- •10.Subject has a genetic mutation or family history of breast/ovarian cancer such that MRI is recommended as a screening modality.
- •11.Subjects with an eGFR of < 30 ml/min/1.73m2.
- •12.Subject has a metallic implant of any type in the chest wall, including pacemakers and implantable defibrillators.
- •13.Subject has inability or unwillingness to comply with all follow-up through to the end of the study, and/or unwilling to allow review of medical records in accordance with local regulatory requirements at time of consent.
- •14.Investigator determines that the subject is not suitable for study participation for any other reason (e.g., Subject has had previous axilla surgery, or lymphatic function that is impaired in the surgeon’s judgment).
研究者
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