Trial Outcomes & Findings for Automated Breast Ultrasound Case Collection Registry (NCT NCT03417024)

NCT ID: NCT03417024

Last Updated: 2019-09-09

Results Overview

• Recruitment status: TERMINATED
• Target enrollment: 13 participants
• Primary outcome timeframe: Up to 6 Years
• Results posted on: 2019-09-09

Participant Flow

Participant milestones

Measure	All Subjects All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices. Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions. Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	All Subjects All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices. Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions. Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.
Overall Study Study Termination prior to follow-up	11
Overall Study Physician Decision	2

Baseline Characteristics

Automated Breast Ultrasound Case Collection Registry

Baseline characteristics by cohort

Measure	All Subjects n=13 Participants All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices. Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions. Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black, African American, or Negro	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic, Latino, or Spanish Origin	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 Years

Population: Study terminated prior to follow-up of any participants. No completed datasets were collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Population: All exams performed for enrolled subjects

Outcome measures

Measure	All Subjects n=13 Participants All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices. Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions. Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.
Type of Exams Performed Per Patient DBT	12 Exams completed
Type of Exams Performed Per Patient ABUS	11 Exams completed

SECONDARY outcome

Timeframe: Up to 6 years

Population: 11 after withdrawals

Outcome measures

Measure	All Subjects n=11 Participants All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices. Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions. Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.
Breast Cancer Status Initial Diagnosis (Cancer)	0 Subjects with findings
Breast Cancer Status Initial Diagnosis (Non-Cancer)	4 Subjects with findings

Adverse Events

All Subjects

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

Sr. Clinical Affairs Project Manager

GE Healthcare

Phone: 2624095722

Email: kevin.r.siewert@ge.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place