NCT02650778

Brief Summary

Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

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

October 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

January 6, 2016

Last Update Submit

April 2, 2023

Conditions

Breast Cancer

Keywords

Breast CancerAutomated whole breast ultrasoundBI-RADS category 3 lesions

Outcome Measures

Primary Outcomes (1)

  • Decreased recall rate for screening breast ultrasound while maintaining cancer detection rate

    3 years

Secondary Outcomes (1)

  • Increased positive biopsy rate

    3 years

Interventions

Breast ultrasoundPROCEDURE

automated whole breast ultrasound

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women age \>18 scheduled for routine screening mammogram. Women with Density 3 or 4 and BIRADS category 1 or mammogram are asked to participate in study

You may qualify if:

  • Women age \>18 scheduled for routine screening mammogram. Women with Density 3 or 4 and BIRADS category 1 or mammogram are asked to participate in study

You may not qualify if:

  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Barr RG, DeSivestri A, Golatta M. Outcomes of Return to Routine Screening for BI-RADS 3 Lesions Detected at Supplemental Automated Whole-Breast Ultrasound in Women With Dense Breasts: A Prospective Study. AJR Am J Roentgenol. 2021 Dec;217(6):1313-1321. doi: 10.2214/AJR.21.26180. Epub 2021 Jul 14.

    PMID: 34259039DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 8, 2016

Study Start

October 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2019

Last Updated

April 4, 2023

Record last verified: 2023-04