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

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-SCR: Recruitment Plan for Asymptomatic Women Undergoing Screening Mammography

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Cancer Screening; Tumors, Breast
• Intervention / Treatment: Device: FFDM; Device: DBT

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health System
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	Device: FFDM; 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device; Other Names: Full-Field Digital Mammogram; 2D breast imaging; Device: DBT; 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device; Other Names: Digital Breast Tomosynthesis; 3D breast imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Imaging Data Collected	Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography.	within 30 days of enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Malfunctions by Modality (DBT or FFDM).	Number of device malfunctions by modality (DBT or FFDM)	Duration of study -approximately 26 months
Cancer-positive Participants	Participants confirmed to be positive for cancer on histology review.	Duration of study - approximately 26 months

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Murray Rebner, MD, Beaumont Health System; Principal Investigator: William Poller, MD, West Penn Allegheny Health System

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 27, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 124.03-2014-GES-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with other researchers