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

July 8, 2020 updated by: Kliniken Essen-Mitte

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ansbach, Germany, 91522
        • Brustzentrum im Klinikum Ansbach
      • Bad Nauheim, Germany, 61231
        • Brustzentrum am Hochwaldkrankenhaus Bad Nauheim
      • Ebersberg, Germany, 85560
        • Kreisklinik Ebersberg, Brustzentrum
      • Esslingen, Germany, 73730
        • Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen
      • Frankfurt a. M., Germany, 60431
        • Agaplesion Markus Krankenhaus Frankfurt, Brustzentrum
      • Georgsmarienhütte, Germany, 49129
        • Franziskus Hospital Harderberg, Brustzentrum Osnabrück
      • Goslar, Germany, 38642
        • Asklepios Harzkliniken Goslar, Brustzentrum
      • Gütersloh, Germany, 33332
        • Klinikum Gütersloh, Klinik für Frauenheilkunde und Geburtshilfe
      • Gütersloh, Germany, 33332
        • Sankt Elisabeth Krankenhaus Gütersloh, Frauenklinik
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Heppenheim, Germany, 64646
        • Kreiskrankenhaus Bergstrasse, Brustzentrum
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Brustzentrum Kiel
      • Magdeburg, Germany, 39108
        • Universitätsfrauenklinik Magdeburg, Brustzentrum
      • Mönchengladbach, Germany, 41061
        • Evangelisches Krankenhaus Bethesda, Brustzentrum Niederrhein
      • Rostock, Germany, 18059
        • Universitätsfrauenklinik am Klinikum Südstadt Rostock
      • Saarlouis, Germany, 66740
        • DRK Krankenhaus Saarlouis, Brustzentrum
      • Schweinfurt, Germany, 97422
        • Leopoldina Krankenhaus Schweinfurt, Brustzentrum
      • Straubing, Germany, 94304
        • Klinikum St. Elisabeth Straubing, Brustzentrum
      • Unna, Germany, 59423
        • Katharinen Hospital Unna, Brustzentrum
      • Weiden, Germany, 92637
        • Kliniken Nordoberpfalz, Frauenklinik
      • Wesel, Germany, 46483
        • Marien-Hospital Wesel, Brustzentrum
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • Kliniken Essen-Mitte
  • Switzerland
      • Bern, Switzerland, 3012
        • Brustzentrum Bern, Engerriedspital/Lindenhofspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: A (access to lymphoscintigraphy)
Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings
Experimental: B (no access to lymphoscintigraphy)
Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings
Procedure: without preoperative access to lymphoscintigraphy findings
axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
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.
histological report on subsequent completion axillary dissection within 6 months after initial sentinel lymph node biopsy
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
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kliniken Essen-Mitte

Collaborators

German Breast Group

Investigators

  • Principal Investigator: Sherko Kümmel, MD, Kliniken Essen-Mitte
  • Study Chair: Thorsten Kühn, MD, Klinikum Esslingen
  • Study Chair: Johannes Holtschmidt, MD, Kliniken Essen-Mitte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SenSzi (GBG80)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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