Trial Outcomes & Findings for Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound (NCT NCT02310776)

Results Overview

Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

501 participants

Primary outcome 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.

Results posted on

2016-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Automated & Handheld Breast US Exams 1. Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist. 2. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist
Overall Study STARTED	501
Overall Study COMPLETED	501
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Automated & Handheld Beast US Exams n=501 Participants 1. Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist. 2. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	461 Participants n=99 Participants
Age, Categorical >=65 years	40 Participants n=99 Participants
Sex: Female, Male Female	501 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	501 participants n=99 Participants

PRIMARY outcome

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.

Population: Each participant was evaluated based on Breast Imaging-Reporting and Data System (BI-RADS) assessment for Automated and Handheld breast ultrasound exams. If participant had more than one lesion, each lesion was assessed and listed separately and if a participant did not have a lesion, she was entered once.

Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians

Outcome measures

Outcome measures
Measure	Automated & Handheld Breast US Exams n=744 Lesions 1. Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist. 2. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist
Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)	1.19 Detection ratio of lesions Interval 1.06 to 1.34

Adverse Events

Automated & Handheld Breast US Exams

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ellen B. Mendelson, MD, FACR, Lee F. Rogers Professor of Medical Education in Radiology, Profess

Northwestern Medicine

Phone: 3124720436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place