Skip to main content
OpenTrials
Completed

NCT Number: NCT02481128

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Early-Stage Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Essen-Mitte, Essen, North Rhine-Westphalia, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

without preoperative access to lymphoscintigraphy findings

Procedure

axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

Primary outcomes

  1. Average number of histologically detected sentinel lymph nodes per patient

    Time frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

    Number of resected sentinel lymph nodes is inversely correlated with false negative rate of sentinel lymph node biopsy. Average number of histologically detected sentinel lymph nodes per patient is assessed through pathologic report and serves as surrogate marker for false negative rate of sentinel node biopsy.

Secondary outcomes

  1. Rate of patients with proven metastasis in sentinel lymph nodes

    Time frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

  2. Rate of completion axillary dissection with proven metastasis in sentinel lymph nodes

    Time frame: histological report on subsequent completion axillary dissection within 6 months after initial sentinel lymph node biopsy

    A completion axillary dissection can be performed in case of proven metastasis in sentinel lymph nodes. A completion axillary dissection ca be performed either right away during sentinel lymph node biopsy or after completion of neoadjuvant chemotherapy. Hence assessment will be performed within 6 months after initial sentinel lymph node biopsy in order to include all patients planned for neoadjuvant chemotherapy.

  3. Detection rates of sentinel nodes lymph nodes with preoperative lymphoscintigraphy vs. intraoperative gamma probe and histological detection rates of sentinel lymph nodes with vs. without preoperative access to lymphoscintigraphy

    Time frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

Sponsors and collaborators

Lead sponsor

Kliniken Essen-Mitte

Other

Collaborators

  • GBG Forschungs GmbH

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 25, 2015
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.