Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

NCT02042456 | Terminated

• 1 other identifier: 124.03-2013-GES-0003
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis

Conditions

Breast Cancer

Keywords

breast cancer; dense breasts; mammography screening; Screening techniques; women

Outcome Measures

Primary Outcomes (1)

• Abnormal interpretation rate

  Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).

  One Year

Secondary Outcomes (5)

• Sensitivity

  One Year

• Specificity

  One Year

• Cancer Rate

  One Year

• Positive Predictive Value

  One Year

• Negative Predictive Value

  One Year

Study Arms (1)

Main Cohort

Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit.

Device: Digital Breast Tomosynthesis; Device: Automated Whole Breast Ultrasound; Device: Full Field Digital Mammography

Interventions

Digital Breast Tomosynthesis DEVICE

digital breast tomosynthesis technology

Also known as: GE SenoClaire DBT with V-Preview

Main Cohort

Automated Whole Breast Ultrasound DEVICE

Automated Whole Breast Ultrasound

Also known as: Invenia ABUS

Main Cohort

Full Field Digital Mammography DEVICE

Main Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from the patients arriving at the clinic for yearly breast cancer screening exams

You may qualify if:

• Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
• Women aged ≥18 years at the time of enrollment;\*
• Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
• At moderately increased or high risk (\>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:
• AND Referred for screening mammography

You may not qualify if:

• Have been screened using any breast imaging technology in \<12 months immediately prior to enrollment;
• Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
• Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
• Are currently pregnant as determined per standard clinical practice at the investigational site;
• Present with contraindications to any imaging examination required in the study protocol;
• Have breast implants; OR
• Are lactating.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 22, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

US (1)