A randomized controlled trial testing hyaluronic acid spacer injection for skin toxicity reduction of Permanent Breast Seed Implant (PBSI) - skin toxicity reduction of permanent breast seed implants

Sint Franciscus Gasthuis0 个研究点目标入组 231 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* Age * 50 years
•* A confirmed histological diagnosis of
•* invasive ductal carcinoma (IDC), Papillary/tubular/cribriform/medullar carcinoma,DCIS or combination of these tumortypes
•* Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
•* A maximum tumor size of 3 cm
•* Clear surgical margins at ink for IDC and * 2 mm for DCIS, or re-excision negative
•* PBSI technically feasible
•* Node negative (axillary lymph node dissection or sentinel node biopsy), nodes with isolated tumor cells are eligible
•* Informed consent signed

•* Lymphovascular invasion
•* Known allergy for hyaluronic acid
•* Neo-adjuvant chemotherapy
•* Active auto immune disorder with severe vasculitis component
•* Uncontrolled and complicated diabetes insulin-dependent
•* Pregnancy
•* Cosmetic breast implants
•* Pacemaker/ICD
•* Psychiatric or addictive disorder that would preclude attending follow-up
•* Post-operative wound infection or abscess following CDC criteria
•* Lobular features on histology (pure or mixed) or sarcoma histology
•* Triple negative tumors
•* Extensive in situ carcinoma
•* Multicentric disease (in more than one quadrant or separated by 2 cm or more)Bilateral breast cancer
•* Recurrent breast cancer
•* Paget*s disease of the nipple
•* Metastases or active other cancer (defined by malignancy in<5 year, excluding curatively treated CIS cervix, Stage 1/grade 1 endometrium carcinoma or successfully treated non-melanoma skin cancer.
•* Patients presenting with a post-surgical fluid cavity * 2.5 cm in diameter in the direction of implanted needled as determined on the planning US, resistant to 4 weeks of hot compresses application
•* Clear delineation of the target volume on CT is not possible (WBR recommended)
•* Having a volume to be implanted over 150cc
•* Having a target volume too close to skin such that the 90% isodose overlaps the skin surface over more than 1 cm2
•* Inability to read Dutch

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