ACTRN12616001696482招募中未知
Can contrast enhanced spectral mammography (CESM) play a clinically useful role in the pre-operative assessment of women with Ductal Carcinoma in Situ (DCIS), the ‘CESM D’ study
Clin. Assoc. Prof. Donna Taylor0 个研究点目标入组 60 人开始时间: 2016年12月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •a. Able to give written informed consent
- •b. Women with one or more pure ductal carcinoma in situ (DCIS) lesion(s) on core biopsy
- •c. Women who are over the ages of 18 at diagnosis
- •d. Women undergoing assessment at Royal Perth Hospital, WA
排除标准
- •a. Inability to give written informed consent (women whose English comprehension is such that they are considered unable to give informed consent will be excluded)
- •b. Evidence of invasive disease within the subject focus of DCIS
- •c. Women who decline or are unfit to have breast surgery
- •d. Women who are pregnant or lactating.
- •e. Contraindications for CESM including
- •i. Previous reaction to contrast media or allergic reaction requiring medical attention
- •ii. Known renal disease (including renal transplant)
- •iii. Diabetes Mellitus (including any patient taking metformin)
- •iv. Poorly controlled asthma
- •v. Known or suspected thyrotoxicosis
- •vi. Patients who are to undergo diagnostic or therapeutic procedures involving radioisotope scanning of the thyroid within 8 weeks of CESM.
- •vii. Known Myasthenia graves
- •viii. Previous administration of IV contrast within 24hours
- •f. Presence of breast implants
- •g. Limited mobility such that the CESM study cannot be completed within 10 minutes of contrast injection
研究者
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