Study Stopped
no patient accrual
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.
2 other identifiers
observational
N/A
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2006
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedApril 13, 2017
April 1, 2017
10 months
September 5, 2012
April 12, 2017
Conditions
Outcome Measures
Primary Outcomes (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
The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =\< 0.7.
at 15 minutes following breast sonogram
Secondary Outcomes (4)
Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes
3 months
Accuracy of lymph node morphology, assessed for shape and echogenicity, to determine guidelines for characterizing micro metastases to the lymph nodes
3 months
Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes
3 months
Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes
3 months
Study Arms (1)
Diagnostic (ultrasound)
Patients undergo breast ultrasound imaging.
Interventions
Undergo ultrasound
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- Patients who have had breast cancer surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Evans
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2012
First Posted
September 10, 2012
Study Start
June 7, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
April 13, 2017
Record last verified: 2017-04