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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01681901
• Other study ID #: OSU-06010
• Secondary ID: NCI-2012-01176
• Status: Withdrawn
• Phase: N/A
• First received: September 5, 2012
• Last updated: April 12, 2017
• Start date: June 7, 2006
• Est. completion date: April 2007

Study information

• Verified date: April 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• ultrasound imaging
Undergo ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   The Jamelsine