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

NCT02306265 | Completed Results

• 1 other identifier: 124.03-2014-GES-0010
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Tumors, Breast; Cancer Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Device Malfunctions by Modality (DBT or FFDM).

  Duration of study -approximately 26 months

• Cancer-positive Participants

  Duration of study - approximately 26 months

Study Arms (1)

DBT and FFDM

OTHER

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; Device: DBT

Interventions

FFDM DEVICE

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

Also known as: Full-Field Digital Mammogram, 2D breast imaging

DBT and FFDM

DBT DEVICE

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

Also known as: Digital Breast Tomosynthesis, 3D breast imaging

DBT and FFDM

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (2)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, 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

Limitations and Caveats

The aim of this study (ADAPT-SCR) was to collect image data using two methods from asymptomatic women undergoing screening mammography. No statistical hypothesis was tested in this image collection study.

Results Point of Contact

• Title: Sara Lam
• Organization: GE Healthcare

Sara.J.Lam@ge.com

1-262-548-2369

Study Officials

• Murray Rebner, MD

  Beaumont Health

  PRINCIPAL INVESTIGATOR

• William Poller, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: May 1, 2015
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: January 29, 2019
• Results First Posted: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)