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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481128
First Posted: June 25, 2015
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Breast Group
Information provided by (Responsible Party):
Kliniken Essen-Mitte
  Purpose
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.

Condition Intervention
Early-Stage Breast Carcinoma Procedure: without preoperative access to lymphoscintigraphy findings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by Kliniken Essen-Mitte:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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.

  • 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 ]

Enrollment: 1198
Study Start Date: May 2014
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481128


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

Responsible Party: Kliniken Essen-Mitte
ClinicalTrials.gov Identifier: NCT02481128     History of Changes
Other Study ID Numbers: SenSzi (GBG80)
First Submitted: June 5, 2015
First Posted: June 25, 2015
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kliniken Essen-Mitte:
lymphoscintigraphy
sentinel lymph node biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases