Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis

NCT03616457 | Withdrawn FDA Device

• 1 other identifier: 110.01-2018-GES-0001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess whether the Invenia™ Automated Breast Ultrasound (ABUS) device, as an adjunct to Digital Breast Tomosynthesis (DBT), improves breast cancer detection in women with dense breasts. The study aims to collect information about cancer detection, treatment, and outcomes based on individual and combined technologies in patients who receive ABUS exams in addition to DBT. The results of this study are intended to be used to extend understanding of ABUS as an adjunct in DBT screening in patients with dense breasts.

Conditions

Breast Cancer

Keywords

Screening Diagnostic

Outcome Measures

Primary Outcomes (1)

• Cancer Detection Rate

  Cancer detection rate of DBT plus ABUS and DBT alone

  up to 16 months

Secondary Outcomes (3)

• Invasive Cancer Detection

  up to 16 months

• Positive Predictive Value

  up to 16 months

• Recall Rates

  up to 16 months

Study Arms (1)

All Study Participants

All study participants will undergo the same study procedures, including Automated Breast Ultrasound (ABUS).

Device: Automated Breast Ultrasound (ABUS)

Interventions

Automated Breast Ultrasound (ABUS) DEVICE

Participants will undergo imaging with ABUS.

All Study Participants

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll asymptomatic adults who are clinically referred for breast cancer screening. Participants in this study will be representative of the clinical population.

You may qualify if:

• Are asymptomatic adult women (aged 40 years or older);
• Are presenting for a DBT breast cancer screening exam;
• Have heterogeneously dense or extremely dense breasts (BI-RADS C or D)
• Are able and willing to participate.

You may not qualify if:

• Have been previously included in this study;
• Have undergone diagnostic or surgical intervention in the last 12 months, including, but not limited to, core or open biopsy, clip placement, fine-needle aspiration, cytopunction, breast reduction or reconstruction, implant removals; OR
• Have had a breast cancer diagnosis or treatment in the past 12 months and have re-entered the screening population.

Sponsors & Collaborators

• GE Healthcare: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Georgia Spear

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 6, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 26, 2018

Record last verified: 2018-10