Lymphatic Mapping After Previous Breast Surgery

NCT01164748 | Completed

• 1 other identifier: NL22080.060.08
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Sentinel Node

Study Arms (2)

Sentinel Node Biopsy

All women who has Sentinel Node Biopsy as their primary treatment of the axilla

Radiation: Lymphoscintigraphy

Axillary Lymph Node Dissection

All women who had Axillary Lymph Node Dissection as primary axillary treatment

Radiation: Lymphoscintigraphy

Interventions

Lymphoscintigraphy RADIATION

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

Also known as: 99mTc-colloidal-albumin

Axillary Lymph Node Dissection; Sentinel Node Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 19, 2010
• Last Updated: July 19, 2010

Record last verified: 2010-07

Locations

NL (1)