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


N/A
55 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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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 CenterColumbus, Ohio  43210