Comparison of Diagnostic Accuracy of Automated Volume Breast Scanner to Hand Held Ultrasound for Diagnostic Breast Exam

NCT02789163 | Completed DMC

• 1 other identifier: AVBS DIAG
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Women age \>18 scheduled for a diagnostic ultrasound examination had both a hand held ultrasound and an automated breast volume scan. Exams were performed by different technologists. Images were blinded and blinded read for diagnostic accuracy of the two examinations

Conditions

Breast Mass

Keywords

breast; ultrasound; diagnostic exam; automated volume breast scanner

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  Diagnostic performance assuming BI-RADS category 1, 2, and 3 were benign and BI-RADS category 4 and 5 were malignant and using biopsy or clinical stability for two years as gold standard was assessed through ROC curves analysis. Sensitivity, specificity, Area Under the Curve (AUC) are presented along with 95% CI. Pairwise comparison of AUC between readers and methodologies are also given using z-statistics (6). P\<0.05 was considered statistically significant. All tests were two-sided.

  one day

Secondary Outcomes (1)

• Comparison of sonographer and mammography technologist performing Automated volume breast scanner

  1 day

Interventions

Ultrasound DEVICE

breast ultrasound; hand held and automated volume breast scanner

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study.

You may qualify if:

• Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study.

You may not qualify if:

• Unable to give informed consent
• breast abnormality greater than one quadrant

Sponsors & Collaborators

• Northeastern Ohio Radiology Research and Education Fund: lead

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Richard G Barr, MD, PhD

  Northeastern Ohio Radiology Research and Education Fund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 2, 2016
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share