Can Radio-guided Occult Lesion Localisation using Iodine-125 Seeds (ROLLIS) for excision of impalpable breast cancer reduce the rate of pathologically inadequate margins and/or subsequent oncological surgery compared with standard hook-wire localisation? A randomised controlled clinical trial.

Prof Christobel SAUNDERS0 个研究点目标入组 659 人开始时间: 2013年6月14日最近更新: 2020年2月10日

适应症

试验速览

暂无简介。

•Women 18 years or over.
•Histologically confirmed invasive or in-situ carcinoma that is impalpable or poorly palpable (such that preoperative localisation is considered to be warranted by the treating surgeon),
•Candidate for breast conserving surgery (BCS), based on clinical and radiological evaluation. Pleomorphic LCIS will be included as it is agreed to be of similar significance to Ductal carcinoma in situ (DCIS).
•Completion of a signed and dated written informed consent obtained prior to participation.

•Male breast cancer - mastectomy is treatment of choice.
•Pregnancy - whilst the radiation dose involved in ROLLIS is very small, the ALARA principle (as low as reasonably achievable) mandates the exclusion.
•Lactation - theoretical possibility of ductal migration of seed.
•More than one separate malignant lesion in the same breast.
•Non-pleomorphic lobular carcinoma in-situ (LCIS) - management remains controversial.

发起方

Prof Christobel SAUNDERS