A study on the use of a hydrogel during breast conserving surgery to improve precision of targeting and positioning of breast irradiation.
Recruiting
- Conditions
- breast cancer, irradiation, hydrogel, target definition, positioning, <br />mammacarcinoom, bestraling, hydrogel, doeldefinitie, positionering
- Registration Number
- NL-OMON28313
- Lead Sponsor
- Erasmus MC- Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
•Woman
•Undergoing breast conserving surgery
Exclusion Criteria
•Oncoplasty technique (level 2 Oncoplastic breast surgery) planned
•Node positive (pre-operatively diagnosed)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the Conformity Index (Cx) of target definition.
- Secondary Outcome Measures
Name Time Method the distance between observers’ target volumes (dCOM), target volumes, Cavity Visualisation Score, feasibility of the hydrogel marker instillation, stability of the hydrogel marker volume over time, adverse events, ease of use, motion of hydrogel marker/clips over time, the feasibility of patient positioning based on the hydrogel marker on cone beam computed tomography (CBCT) and planar kV images and the accuracy of this procedure compared to positioning based on the surgical clips.