breast cancer, multifocal breast cancer, sentinel lymph node
Conditions
Interventions
Patients who are scheduled for a sentinel node procedure will receive two injections with radioactive labelled nanocolloid. In the (most) medial tumor ICG-99mTc-nanocolloid will be administered, in th
Sponsors
NKI-AVL
Rijnland ziekenhuis Leiderdorp
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients presenting at one of the participating centers with two or three invasive tumors in one or more quadrants of the breast 2. The minimal distance between two different invasive foci must be two centimeters 3. The minimal diameter of an invasive focus (of one tumor) must be one centimeter 4. Patients are clinically staged with negative lymph nodes in the axilla.
Exclusion criteria
Exclusion criteria: 1. The maximum diameter of the tumor larger than five centimeters 2. Evidence of other breast-cancer related disease such as palpable or ultrasound detected lymph node metastases or distant metastases. 3. Exclusive presence of ductal carcinoma in situ (DCIS). 4. Incapacity or unwillingness of participant to give written informed consent 5. Patients with known allergy to patent blue; 6. Patients who are pregnant or nursing mothers 7. History of hypersensitivity reactions to products containing human serum albumin 8. History of iodine allergy 9. Hyperthyroid or thyroidal adenoma 10. Kidney insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is to determine the clinical value of the sentinel node procedure in breast cancer patients with multiple tumors and to investigative whether an intratumoral injection of the radiopharmaceutical in each tumor will lead to identification of additional sentinel nodes and/or extra lymphatic drainage locations compared to an intratumoral injection of the radiopharmaceutical in the largest tumor only. | — |
Contacts
Public ContactH.S.A. Oldenburg
Outcome results
None listed