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CompletedNCT01164748LABSUpdated Jul 19, 2010

Lymphatic Mapping After Previous Breast Surgery

An observational study in Breast Cancer and Sentinel Node, sponsored by Catharina Ziekenhuis Eindhoven. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-19.

Sponsored by Catharina Ziekenhuis Eindhoven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Sentinel Node
03

In context

Lead sponsor

Catharina Ziekenhuis Eindhoven is the lead sponsor of 80 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective

Groups and cohorts

  • 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

  • RadiationLymphoscintigraphy

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

    Also known as: 99mTc-colloidal-albumin

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Study locations

1 site
  • Catharina Hospital
    Eindhoven, 5623 EJ, Netherlands
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01164748
Lead sponsor
Catharina Ziekenhuis Eindhoven
First posted
Jul 19, 2010
Last update
Jul 19, 2010
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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