Lymphatic Mapping After Previous Breast Surgery

Breast Cancer Clinical Trial

— LABS  

Official title:

Lymphatic Mapping After Previous Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164748
• Other study ID #: NL22080.060.08
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: July 16, 2010

Study information

• Verified date: July 2010
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Sentinel Node

Intervention

Radiation:
• Lymphoscintigraphy
in all women a lymphoscintigraphy was done to investigate drainage patterns of a previous operated breast and axilla

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands,