Lymphatic Mapping After Previous Breast Surgery (LABS)

This study has been completed.
Sponsor:
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01164748
First received: July 16, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Sentinel Node
Radiation: Lymphoscintigraphy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lymphatic Mapping After Previous Breast Surgery

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 99mTc-colloidal-albumin

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164748

Locations
Netherlands
Catharina Hospital
Eindhoven, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01164748     History of Changes
Other Study ID Numbers: NL22080.060.08
Study First Received: July 16, 2010
Last Updated: July 16, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on October 21, 2014