Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.
55 Years
N/A
Female
Breast Cancer
Trial Information
Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
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
Outcome Description:
The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =< 0.7.
Outcome Time Frame:
at 15 minutes following breast sonogram
Safety Issue:
No
Principal Investigator
Kevin Evans
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
OSU-06010
NCT ID:
NCT01681901
Start Date:
June 2006
Completion Date:
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| The Ohio State University Medical Center | Columbus, Ohio 43210 |
