Breast Cancer
Conditions
Brief summary
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
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.
Interventions
PROCEDUREultrasound imaging
Undergo ultrasound
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | at 15 minutes following breast sonogram | The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =\< 0.7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes | 3 months | 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. |
| Accuracy of lymph node morphology, assessed for shape and echogenicity, to determine guidelines for characterizing micro metastases to the lymph nodes | 3 months | 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. |
| Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes | 3 months | 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. |
| Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes | 3 months | 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. |
Outcome results
None listed