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

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography ADAPT-Enrich: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy After Screening Digital Breast Tomosynthesis Exam

The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other performance measures.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Tumors, Breast
• Intervention / Treatment: Device: DBT and FFDM

Detailed Description

ADAPT-ENRICH will supplement an on-going program (ADAPT) which consists of 2 additional 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 be recruited from an initially asymptomatic population that have been referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. Subjects will undergo a DBT mammogram prior to biopsy. If FFDM was not performed within 30 days, subjects will also undergo FFDM prior to biopsy. Results of biopsy(ies) and histopathology, including lesion characteristics, will be recorded and considered as truth if positive for cancer status. Subjects with negative or benign histological findings will be followed for approximately one year (10-16 months) by FFDM and any additional standard of care practice.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Carolina Breast Imaging Specialists
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Breast Center

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);
• Initially asymptomatic women who underwent routine bilateral screening with Digital Breast Tomosynthesis (DBT), followed by diagnostic work-up showing one or more abnormalities and referred for breast biopsy;
• Are able and willing to comply with study procedures;
• Have signed and dated the informed consent form;
• Documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy.

Exclusion Criteria:

• Have been previously included in this study , ADAPT-SCR recruitment plan or ADAPT-BX recruitment plan;
• Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including mastectomy and cytopunction, before study-related imaging;
• Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) DBT or FFDM digital receptor without anatomical cut-off during a DBT or FFDM 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: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: DBT and FFDM; Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).	Device: DBT and FFDM; Subjects underwent FFDM breast imaging followed by DBT breast imaging; Other Names: Digital Breast Tomosynthesis (3D breast imaging) DBT; Full-Field Digital Mammography (2D breast imaging) FFDM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With DBT, FFDM and Biopsy Specimens Collected	For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.	Approximately 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Type Observed by FFDM Imaging	Lesions were characterized based on findings identified during image evaluations performed by qualified readers.	Approximately 8 weeks
Lesion Type Observed by DBT Imaging	Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.	Approximately 8 weeks
Lesion Size as Observed by FFDM	Length of Lesions (measured in mm) when images were collected using FFDM.	Approximately 8 weeks
Lesion Size as Observed by DBT	Length of lesions (measured in mm) when images were collected using DBT.	Approximately 8 weeks
Biopsy Finding of Lesions	Describes histologic cancer and non-cancer findings of lesion biopsy.	Approximately 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Device Related Malfunctions	Number of device-related malfunctions by imaging modality.	Approximately 8 weeks

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 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: 124.03-2015-GES-0001