Feasibility study to assess the incremental value of DeclipseSPECT during radioactive seed localisation in breast cancer surgery.
Completed
- Conditions
- 1000629110006295Breast cancerBreast tumour
- Registration Number
- NL-OMON40653
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- Woman
- Age > 18
- Histological proven breast cancer
- I-125 seed at the right place in the tumour
- Scheduled for breast tumour lumpectomy by RSL
- Patients Provide writen *informed consent*
Exclusion Criteria
- A pre-treated breast tumour.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective: The primary objective of the present study is to assess the<br /><br>feasibility of using the declipseSPECT system for accurate I-125 seed<br /><br>localisations in breast cancer surgery.<br /><br>• The outcome is a subjective opinion of the surgeon where it states that the<br /><br>declipseSPECT is useful or not for I-125 seed localisations and depth<br /><br>indications. This is scored by a 5-point scale.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Endpoint: Assess the accuracy of I-125 seed detection with freehand-SPECT<br /><br>compared to conventional gamma probe localisation.<br /><br>• The outcome will be a distance in mm for the mismatch between the<br /><br>conventional gamma probe measurement and the freehand-SPECT localisation on the<br /><br>skin.<br /><br>Endpoint: To determine if it is feasible to predict the accuracy of a tumour<br /><br>excision based on the location of the I-125 in the excision specimen.<br /><br>• The outcome will be a measure for eccentricity of the I-125 in the specimen.<br /><br>The closest margin will be written down. </p><br>