Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

NCT ID: NCT02306265

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-07-07

Brief Summary

The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.

Detailed Description

ADAPT program consists of 2 recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an off-line read of the images and data collected (ADAPT-BIE). This study involves the comparison of two devices that can identify abnormalities in routine breast screening and diagnostic mammography. Mammography is usually done with full-field digital mammography (FFDM), which takes flat, two-dimensional X-ray images of the breast. Doctors use the two-dimensional images to look for cancers and other abnormal tissue. The purpose of this study is to learn more about the accuracy of full-field digital mammography devices and a new mammography device called digital breast tomosynthesis (DBT). DBT is similar to full-field digital mammography, but can also move around the breast to get X-ray images from different angles, which provides a three-dimensional view that doctors can use to look for cancers and abnormal tissue. Subjects will undergo routine imaging with FFDM and will also have a DBT performed. They will continue with their standard of care treatment as would occur outside of the study. Based on the results of the FFDM and DBT, the subject's status will be followed-up with routing imaging at approximately 1 year (10-16 months). If the doctor recommends biopsy based on the FFDM or DBT, information about the biopsy and cancer determination results will be collected. Being in this study does not require subjects to have a biopsy that was not recommended by the doctor for normal medical care.

Conditions

Breast Cancer; Tumors, Breast; Cancer Screening

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

DBT and FFDM

Subjects will undergo 2D breast imaging with full-field digital mammography (FFDM) device (active comparator) and 3D breast imaging with digital breast tomosynthesis (DBT) device (experimental).

Group Type: OTHER

FFDM

Intervention Type: DEVICE

2D imaging of the breast using Full-Field Digital Mammography (FFDM) device

DBT

Intervention Type: DEVICE

3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device

Interventions

FFDM

2D imaging of the breast using Full-Field Digital Mammography (FFDM) device

Intervention Type: DEVICE

DBT

3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device

Intervention Type: DEVICE

Other Intervention Names

Full-Field Digital Mammogram; 2D breast imaging; Digital Breast Tomosynthesis; 3D breast imaging

Eligibility Criteria

Inclusion Criteria

• Women aged 30 years or older (≥30 years old);
• Asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days;
• Mammography completed on a General Electric (GE) GE FFDM system (with craniocaudal (CC) and mediolateral oblique (MLO) views) at the site or another clinical facility;
• Are able and willing to comply with study procedures;
• Have signed and dated the informed consent form;
• Are either surgically sterile or postmenopausal or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, a negative urine pregnancy test (if subject requests one).

Exclusion Criteria

• Have been previously included in this study;
• Have a history of breast cancer and are in active treatment. However, subjects with a prior lumpectomy (> 5 years prior) who receive only routine screening mammography views can be included;
• Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during either FFDM or DBT examination;
• Have participated in (within the prior 30 days) another trial of an investigational product expected to interfere with study procedures or outcomes;
• Have breast implant(s);
• Have reconstructed breast(s).

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Murray Rebner, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Health

William Poller, MD

Role: PRINCIPAL_INVESTIGATOR

West Penn Allegheny Health System

Locations

Beaumont Health System

Royal Oak, Michigan, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

124.03-2014-GES-0010

Identifier Type: -

Identifier Source: org_study_id