We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01681901
Recruitment Status : Withdrawn (no patient accrual)
First Posted : September 10, 2012
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Brief 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

Condition or disease Intervention/treatment
Breast Cancer 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
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.
Actual Study Start Date : June 7, 2006
Estimated Primary Completion Date : April 2007
Estimated Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]
    The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =< 0.7.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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. Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes [ Time Frame: 3 months ]
    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.

  4. Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681901


Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Kevin Evans Ohio State University Comprehensive Cancer Center

Additional Information:
Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01681901     History of Changes
Other Study ID Numbers: OSU-06010
NCI-2012-01176 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017