Multicenter studie naar de klinische relevantie van één injectie per tumor voor de schildwachtklierprocedure bij patiënten met multiple borsttumoren

Lymphoscintigraphy in breast cancer patients can determine the lymphatic drainage pattern and the location of the first draining lymph nodes, the sentinel nodes. Sentinel nodes are likely to be the first nodes to harbor tumor cells, which may alter the patients’ management. The purpose of this study is to further establish the clinical value of lymphoscintigraphy and sentinel node biopsy in patients with multiple invasive tumors in one ore more quadrants of the breast. In a first evaluation of the M08ML study including 50 patients receiving separate tumor 99m Tc-nanocolloid injections a 64% additional lymphatic drainage was found after tracer administration in the smaller tumors of the breast.1 In only 5 patients the additionally detected sentinel nodes contained tumor; however, in these patients also the sentinel nodes draining from the largest tumor contained metastases. In two other patients isolated tumor cells were found only in the additional sentinel nodes. Based on the findings of this first evaluation, and following the recommendations of the reviewers of the manuscript, the investigators consider a follow-up to the study as necessary. In this modified follow-up study an additional number of patients will be evaluated in order to demonstrate, or exclude, the clinical relevance of the additional sentinel nodes. In order to simplify the protocol all tumors in the breast will be injected at the same time.

AIM: Establish the clinical value of sentinel node biopsy in patients with multiple breast tumors. Investigate if an intratumoral tracer injection in the additional tumors results in visualization of extra sentinel nodes/extra lymphatic drainage basins in comparison to an intratumoral injection in the largest tumor (standard).

HYPOTHESIS: There is a difference in lymphatic drainage pattern (and thereby the number /location of the sentinel node(s)) between the largest tumor and the additional tumors.

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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 the lateral tumor(s) the standard 99mTc-nanocolloid is injected. After both injections the normal procedure will be followed.