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

NCT02481128 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1198

Last updated 2020-07-09

No results posted yet for this study

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.

Conditions

  • Early-Stage Breast Carcinoma

Interventions

PROCEDURE

without preoperative access to lymphoscintigraphy findings

axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

Sponsors & Collaborators

  • GBG Forschungs GmbH

    collaborator OTHER

  • Kliniken Essen-Mitte

    lead OTHER

Principal Investigators

  • Sherko Kümmel, MD · Kliniken Essen-Mitte

  • Thorsten Kühn, MD · Klinikum Esslingen

  • Johannes Holtschmidt, MD · Kliniken Essen-Mitte

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481128 on ClinicalTrials.gov