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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Kevin Evans, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01681901
First received: September 5, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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


Condition Intervention
Breast Cancer
Procedure: ultrasound imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: at 15 minutes following breast sonogram ] [ Designated as safety issue: No ]
    The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =< 0.7.


Secondary Outcome Measures:
  • Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 110
Study Start Date: June 2006
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (ultrasound)
Patients undergo breast ultrasound.
Procedure: ultrasound imaging
Undergo ultrasound
Other Names:
  • ultrasonography
  • ultrasound
  • ultrasound test

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681901

Locations
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Kevin Evans, PhD,RT,RDMS,RVS    614-688-4535    Kevin.Evans@osumc.edu   
Principal Investigator: Kevin Evans, PhD,RT,RDMS,RVS         
Sponsors and Collaborators
Kevin Evans
Investigators
Principal Investigator: Kevin Evans Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Kevin Evans, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01681901     History of Changes
Other Study ID Numbers: OSU-06010, NCI-2012-01176
Study First Received: September 5, 2012
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014