NCT02481128

Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer

Randomized Controlled Multicenter Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer; SenSzi (GBG80)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,198 (actual)
• Sponsor: Kliniken Essen-Mitte · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Early-Stage Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	without preoperative access to lymphoscintigraphy findings	axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2015-06-25
• Last updated: 2020-07-09

Locations

23 sites across 2 countries: Germany, Switzerland