Ultrasound in Detecting Lymph Node Metastasis in Older Patients Undergoing Breast Sonography

Study Overview
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Brief Summary
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This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may help find breast cancer and find out how far the disease has spread

Detailed Description
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PRIMARY OBJECTIVES: I. To develop a reliable and consistent set of guidelines for utilizing diagnostic ultrasound to assess axillary lymph nodes for patient suspicious of breast cancer with possible nodal metastasis. SECONDARY OBJECTIVES: I. To explore whether the data collected can be used for pathologic validation of metastatic disease. OUTLINE: Patients undergo breast ultrasound.

Official Title
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Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: ultrasound imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for a breast ultrasound Patients who have had a mammogram with a Breast Imaging Reporting and Data System (BIRADS) of >= 4 Patients who are undiagnosed for breast cancer Exclusion Criteria: Patients who have had breast cancer surgery

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (ultrasound)<br>Patients undergo breast ultrasound imaging. | Procedure: ultrasound imaging<br>* Undergo ultrasound<br>* Other names: ultrasound test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of successful evaluations, defined as the consistent capture of the data for geometry, morphology, qualitative vascular information, and quantitative vascular information on 3 axillary lymph nodes | The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =< 0.7. | at 15 minutes following breast sonogram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes | Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The longitudinal-transverse ratio will be investigated for cutoff points that yield high sensitivity and to see if results are consistent with prior studies suggesting a ratio of 1.5 or less is indicative of abnormality. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed. | 3 months | 
| Accuracy of lymph node morphology, assessed for shape and echogenicity, to determine guidelines for characterizing micro metastases to the lymph nodes | Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed. | 3 months | 
| Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes | Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed. | 3 months | 
| Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes | Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed. | 3 months |