Early-Stage Breast Carcinoma Clinical Trial
Official title:
Randomized Controlled Multicenter Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer; SenSzi (GBG80)
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.
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