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

Breast Mass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789163
• Other study ID #: AVBS DIAG
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: May 27, 2016
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: May 2016
• Source: Northeastern Ohio Radiology Research and Education Fund
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Description:

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. If the patient had both a palpable mass and a mammogram that had an abnormality the indication was listed as a palpable abnormality. Exclusion criteria included inability to give informed consent and abnormality of the breast that is larger than one quadrant. No patients were excluded from the study.

All patients received both a Hand Held (HH) and Automated Breast Volume Scanner (ABVS) ultrasound. Patients were initially randomized to have either a HH or an ABVS. The HH ultrasound was performed by one of 4 sonographers that had a minimum of 10 years experience in breast ultrasound. A different sonographer than the one performing the HH or mammography technician performed ABVS. All technologists performing ABVS participated in a training course on ABVS and performed at least 10 patients satisfactorily before beginning the study. The choice of a mammography technician or sonography to perform the ABVS was randomized. Both the sonographer performing the HH and the sonographer or mammography technologist performing the ABVS were provided the patient's history and results of the mammogram if performed for placement of the ABVS and region of interest for the HH. However the results of the HH or ABVS were not available to the person performing the second examination.

Final diagnosis was performed either by a 12 gauge core biopsy (Celero, Hologic, Marlborough, MA ) or confirmation of a benign lesion by no significant change over 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Unable to give informed consent

• breast abnormality greater than one quadrant

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Mass

Intervention

Device:
• Ultrasound
breast ultrasound; hand held and automated volume breast scanner

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northeastern Ohio Radiology Research and Education Fund

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparison of sonographer and mammography technologist performing Automated volume breast scanner	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.	1 day	No