Contouring Conformance comparing Barrigel® with Surgical Clips for Post-Lumpectomy Cavity Delineation in Breast Cancer - Trial ANZCTR12623000470695

Timeline & Enrollment

Primary Outcome

Inter-observer variability of the delineated tumour bed using the overlap difference of contours using clips and CT versus gel and MRI.

Summary

This study aims to determine whether Barrigel (hyaluronic acid gel) can delineate the tumour bed after breast cancer surgery Who is it for? You may be eligible to join this study if you have been diagnosed with early breast cancer and planned for wide local excision (WLE) and sentinel lymph node biopsy (SLNB) Study details All participants in this study will have both Barrigel and standard surgical clips applied following wide local incision of the breast cancer. Approximately 4-6 weeks after surgery (or after chemotherapy if needed), participants will undergo computed tomography (CT) scans and magnetic resonance imaging (MRI) scans to visualise the gel and clip placements. A group of doctors will then independently contour out where they think the tumour bed is, and the degree of overlap of each contour will help determine its efficacy. Participants will then be assessed annually for up to 2 years using routine surveillance breast mammography and ultrasound to determine gel presence and characteristics over the long-term. It is hoped that this research project will provide us more information about alternative ways to improve the accuracy of post-operative radiotherapy planning and treatment in early breast cancer, especially as MRI guided planning and treatment becomes more prevalent.

ICD-10 Classifications