Pilot study on the use of a radiopaque hydrogel during breast conserving surgery with full-thickness closure for target definition and positioning of boost or partial breast irradiation.
Phase 2
Completed
- Conditions
- breast cancerbreast carcinoma1000629110006295
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
* Woman
* Undergoing breast conserving surgery
* Indication for radiotherapy
* Full thickness closure (level 1 oncoplastic breast surgery) planned
* Written informed consent
Exclusion Criteria
* Oncoplasty technique (level 2 Oncoplastic breast surgery) planned
* need for adjuvant chemotherapy
* Allergy for PEG
* Allergy for Iodine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>primary endpoint: the Conformity Index (Cx) of target definition.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints: the distance between observers* target volumes (dCOM),<br /><br>target volumes, Cavity Visualisation Score, feasibility of the hydrogel marker<br /><br>instillation, stability of the hydrogel marker volume over time, adverse<br /><br>events, ease of use, motion of hydrogel marker/clips over time, the feasibility<br /><br>of patient positioning based on the hydrogel marker on cone beam computed<br /><br>tomography (CBCT) and planar kV images made on a conventional linac and a<br /><br>Cyberknife and the accuracy of this procedure compared to positioning based on<br /><br>the surgical clips.</p><br>