Pure Global AI
ANZCTR12623000470695Recruitment Completed

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

Austin HealthNot ApplicableAustralian New Zealand Clinical Trials RegistrydeviceDevice trial
VerifiedAustralian New Zealand Clinical Trials Registry
Study focus
Disease/Condition
breast cancer
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Austin Health
Funder
Austin Health;; Palette Life Sciences
Location
Australia
Timeline & enrollment
Phase
Not Applicable
Start date
May 28, 2021
End date
Aug 17, 2022
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
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12623000470695
Type
Device Trial
About this record

Access comprehensive clinical trial information for ANZCTR12623000470695 through Pure Global AI's free database. This Not Applicable trial is sponsored by Austin Health and is currently Recruitment Completed. The study focuses on breast cancer.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Australian New Zealand Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.