ACTRN12612000221853已完成未知
ROLLIS: Radioguided Occult Lesion Localisation using Iodine Seeds to localise impalpable breast lesions: The Pilot Extension Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 120
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
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. Women aged over 40 years
- •2. Non-palpable breast tumour
- •4. Participant eligible for breast conserving surgery (BCS)
- •based on clinical and radiologic evaluation
- •6. Benign impalpable lesions, where participant requests
- •lesion be removed
- •7. Intraductal lesions (papillomas)
- •8. Lesions that are histologically indeterminate” on core
- •biopsy ( histology shows concerning features and removal
- •of further tissue for assessment to exclude cancer)
- •9. Insertion of up to two seeds per participant (either
- •to bracket” larger or elongated lesions or for multiple
- •lesions (two in one breast or one in each breast)
- •10.Periareolar lesions (providing the participant does not
- •require scintigraphy for sentinel node biopsy)
排除标准
- •1. Male patient
- •2. Female, age less than 40 years
- •3. Pregnancy or lactation
- •4. Periareolar lesion (where sentinel lymph node localization is
- •5. Contraindication to breast conserving surgery
- •6. Recent Nuclear Medicine or PET radioisotope administration that may adversely affect the procedure (isotopes with long half life eg gallium 67, thallium )
研究者
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