Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer
Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer
Sentinel node biopsy is a well established tool for axillary staging in early breast cancer.
 So far the impact of a preoperative lymph node scintigraphy is unclear. This study aims to
 clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective
 randomized multicenter study design.
Sentinel node biopsy is a well established tool for axillary staging in early breast cancer.
 So far the impact of a preoperative lymph node scintigraphy is unclear. Several studies
 indicate sentinel node biopsy to be a reliable method irrespective of prior lymph node
 scintigraphy, but data from prospective randomized trials are not available.

 Although a preoperative lymph node scintigraphy is not explicitly demanded in current S3
 guidelines in Germany its performance is a common practice.

 If a preoperative lymphoscintigraphy could be safely omitted, possible benefits are a
 facilitation of the preoperative workflow as well as cost reduction for health care systems.

 This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit
 in a prospective randomized study design. In the two study arms sentinel node biopsy is
 performed either with or without knowledge of the preoperative lymphoscintigraphy findings.
 Primary end point is the average number of histologically detected sentinel lymph nodes per
 patient in both treatment arms.
Inclusion Criteria:

 -  invasive mamma carcinoma as verified by core cut biopsy

 -  extensive ductal carcinoma in situ as verified by core cut biopsy (at least 5 cm or at
 least 2,5 cm and G3 grading)

 -  clinical stage tumor T1-T3

 -  no signs of axillary lymph node metastasis on clinical examination including
 ultrasound examination

 -  no signs of distant metastatic disease

 -  male/ female patient in the age not less than 18 years

 -  Karnofsky performance status at least 70% or Eastern Cooperative Oncology Group (ECOG)
 score not higher than 1

 -  written patient informed consent

 Exclusion Criteria:

 -  suspect axillary lymph nodes on clinical/ultrasound examination

 -  positive fine-needle biopsy of axillary lymph nodes

 -  sentinel lymph node biopsy to be performed after neoadjuvant chemotherapy

 -  recurrence of a mamma carcinoma

 -  prior extensive surgery of breast or axilla

 -  inflammatory or extramammary breast cancer

 -  pregnancy

 -  contraindication to the radionuclide

 -  inability to understand the studies purpose

 -  inability to receive surgery

 -  no written patient informed consent