A radiopaque hydrogel to improve target definition of boost or partial breast irradiation in patients with low cavity visualization scores

• Conditions: breast cancer; breast carcinoma; 10006291; 10006295

• Registration Number: NL-OMON46264
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Women following breast conserving surgery for breast cancer and/or ductal carcinoma in situ (DCIS) with an indication for boost or partial breast radiotherapy according to local protocol of the Erasmus MC.
CVS score 1-3 on original CT-planning for radiotherapy.
written informed consent

Exclusion Criteria

Oncoplastic technique (level 2: volume replacement) performed
Patients with known allergies for PEG or Iodine
No surgical scar visible / post-operative effects visible on US

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>injection, stability of the hydrogel marker volume over time, adverse events,<br /><br>ease of use, motion of hydrogel marker/clips over time, feasibility of using<br /><br>the hydrogel for patient positioning and comparison of dose to organs at risk<br /><br>for treatment plans with and without hydrogel.</p><br>