NCT02310776

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 8, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 9, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

November 25, 2014

Results QC Date

April 21, 2015

Last Update Submit

January 7, 2016

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (1)

  • Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)

    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

    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.

Study Arms (1)

Automated & Handheld breast US exams

OTHER

1. Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner. 2. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound.

Device: Supine automated breast ultrasound scannerDevice: High-resolution handheld breast ultrasound

Interventions

Supine automated breast ultrasound scannerDEVICE

Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.

Automated & Handheld breast US exams
High-resolution handheld breast ultrasoundDEVICE

Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist

Automated & Handheld breast US exams

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • anyone who is referred for an ultrasound of the breast

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Weinstein Imaging

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Ellen B. Mendelson, MD, FACR, Lee F. Rogers Professor of Medical Education in Radiology, Profess
Organization
Northwestern Medicine
emendels@nm.org
3124720436

Study Officials

  • Ellen B Mendelson, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FACR, Lee F. Rogers Professor of Medical Education in Radiology, Professor of Radiology Feinberg School of Medicine

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 8, 2014

Study Start

June 1, 2012

Primary Completion

March 1, 2014

Study Completion

October 1, 2015

Last Updated

February 9, 2016

Results First Posted

May 8, 2015

Record last verified: 2016-01

Locations

US(2)