MULTICENTER FEASIBILITY STUDY OF THE SENTINEL NODE PROCEDURE IN PATIENTS WITH MULTIPLE BREAST TUMORS
- Conditions
- breast cancerbreast neoplasms1000629110006295
- Registration Number
- NL-OMON32855
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Patients presenting with multiple invasive tumors in one or more quadrants of the breast.
The minimal distance between two different invasive foci must be two centimeters.
The minimal diameter of an invasive focus (of one tumor) must be one centimeter.
Exclusion Criteria
The maximum diameter of an invasive focus (one tumor) must be five centimeters.
The maximum number of present invasive foci in one breast must be three tumors.
Evidence of other breast-cancer related disease such as palpable or ultrasound detected lymph node metastases or distant metastases.
Exclusive presence of ductal carcinoma in situ (DCIS).
Incapacity or unwillingness of participant to give written informed consent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Number of sentinel nodes after first injection<br /><br>2. Extra number of sentinel nodes after second injection<br /><br>3. Different locations of sentinel nodes after first injection<br /><br>4. Extra locations of sentinel nodes after second injection<br /><br>5. Analysis of the possible differences in lymphatic drainage<br /><br>between patients with multifocal and multicentric tumors</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Lymph node recurrences<br /><br>2. Overall and disease-free survival</p><br>