Can the use of low dose radioactive seeds to guide surgical removal of small areas of abnormal breast tissue reduce the rate of second operation compared with standard hook-wire technique? (ROLLIS RCT: Radio-guided Occult Lesion Localisation using Iodine-125 Seeds)

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12613000655741
• Lead Sponsor: Prof Christobel SAUNDERS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-14
• Study Completion: 2019-12-10
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 659

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified