Lymphatic Mapping After Previous Breast Surgery (LABS)

July 16, 2010 updated by: Catharina Ziekenhuis Eindhoven

Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate staging.

Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast surgery. A second goal is to investigate whether or not previous breast surgery (with or without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

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

  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

We included patients that received BCT with SNB and/or ALND for primary breast cancer located in the upper-outer quadrant of one breast at least 3 years before this analysis. Patients were excluded if they had breast surgery for other reasons than breast cancer, had recurrent breast cancer or had a former allergic reaction to 99mTc-colloidal-albumin.

44 patients were included and were divided into two groups according to previous surgical treatment of the axilla, being the sentinel node biopsy group and the Axillary Lymph Node Dissection group

Description

Inclusion Criteria:

  • treatment with BCT with SNB and/or ALND for primary breast cancer
  • previous primary breast cancer located in the upper-outer quadrant of one breast
  • Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo- or hormonal therapy.

Exclusion Criteria:

  • breast surgery for other reasons than breast cancer
  • recurrent breast cancer
  • former allergic reaction to 99mTc-colloidal albumin.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sentinel Node Biopsy
All women who has Sentinel Node Biopsy as their primary treatment of the axilla
Radiation: Lymphoscintigraphy
in all women a lymphoscintigraphy was done to investigate drainage patterns of a previous operated breast and axilla
Other Names:
  • 99mTc-colloidal-albumin
Axillary Lymph Node Dissection
All women who had Axillary Lymph Node Dissection as primary axillary treatment
Radiation: Lymphoscintigraphy
in all women a lymphoscintigraphy was done to investigate drainage patterns of a previous operated breast and axilla
Other Names:
  • 99mTc-colloidal-albumin

Collaborators and Investigators

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

Sponsor

Catharina Ziekenhuis Eindhoven

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 Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (ESTIMATE)

July 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2010

Last Update Submitted That Met QC Criteria

July 16, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • NL22080.060.08

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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