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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: ultrasound imaging

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic (ultrasound); Patients undergo breast ultrasound imaging.	Procedure: ultrasound imaging; Undergo ultrasound; Other Names: ultrasonography; ultrasound; ultrasound test

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Kevin Evans, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamelsine

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2006
• Primary Completion (Anticipated): April 1, 2007
• Study Completion (Anticipated): April 1, 2007

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 5, 2012
• First Posted (Estimate): September 10, 2012

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: OSU-06010; NCI-2012-01176 (Registry Identifier: CTRP (Clinical Trial Reporting Program))