Clinical trial NCT02310776: Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound
Official title: Breast Lesion Detection Using the Acuson S2000 Automated Breast Volume Scanner (ABVS) Compared With Handheld (HH) Physician-performed Ultrasound (US) Examinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Diseases
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2014-12-08
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.

Detailed description: This is a research study to test a FDA-approved automated breast ultrasound (ABVS) machine in subjects recommended for an ultrasound of the breast. The main purpose of the study is to compare images obtained from the automated breast ultrasound exam with the standard physician performed handheld breast ultrasound exam for lesion detection equivalence.

Each subject will have a bilateral hand-held breast ultrasound and a bilateral automated breast ultrasound, both exams preferably done on the same day. The hand-held ultrasound will be performed by a breast imaging physician participating in the study and the automated ultrasound exam will be performed by a sonographer.

There is no radiation risk from ultrasound. The physician performing the handheld breast ultrasound is blinded to the study, will not know the subject's history, but only the reason for the breast ultrasound exam.

The automated scan requires gentle pressure on the breast during a scan. Three basic views will be acquired for each breast, each scan lasting approximately one minute. Once all necessary views are acquired, the images will be sent to a remote workstation, where a second radiologist, also blinded to the results of the handheld study, will interpret the automated ultrasound.

Once all images and patient information are gathered, the study radiologists will review the previous images, if available, to provide the final result that will determine clinical management. Therefore, it is possible that the hand-held or automated ultrasound scan will lead to further evaluation of the breast and possibly a biopsy.

Eligibility criteria: Inclusion Criteria:

* anyone who is referred for an ultrasound of the breast

Exclusion Criteria:

* Subjects whose breast thickness is greater than 6 cm.The maximum depth of image filed for the ABVS acquisition is 6 cm

Primary outcomes:
measure: Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)
timeFrame: Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Pittsburgh
country: United States
facility: Weinstein Imaging
state: Pennsylvania
Study officials:
affiliation: Northwestern University
name: Ellen B Mendelson, MD
role: PRINCIPAL_INVESTIGATOR
References: