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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01176 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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no patient accrual
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (ultrasound) | Patients undergo breast ultrasound imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound imaging | Procedure | Undergo ultrasound |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Evans | Ohio State University Comprehensive Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| The Jamelsine | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D055585 |
| Physical Phenomena |