Lymphatic Mapping After Previous Breast Surgery

NCT ID: NCT01164748

Last Updated: 2010-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Sentinel Node

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sentinel Node Biopsy

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

Lymphoscintigraphy

Intervention Type RADIATION

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

Axillary Lymph Node Dissection

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

Lymphoscintigraphy

Intervention Type RADIATION

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

Interventions

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Lymphoscintigraphy

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

Intervention Type RADIATION

Other Intervention Names

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99mTc-colloidal-albumin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Locations

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Catharina Hospital

Eindhoven, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL22080.060.08

Identifier Type: -

Identifier Source: org_study_id

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