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

NCT02324205 | Terminated Results

• 1 other identifier: 124.03-2014-GES-0010_2
• Study Type: interventional
• Target: 196
• Locations: 2 countries
• Sites: 3

Brief Summary

The aim of this recruitment plan (ADAPT-BX) 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 biopsy after recall from screening and diagnostic work-up. 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 clinical performance measures.

Conditions

Breast Cancer; Tumors, Breast

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Lesion Type Observed by FFDM Imaging

  Approximately 8 weeks

• Lesion Type Observed by DBT Imaging

  Approximately 8 weeks

• Maximum Lesion Dimension as Observed by FFDM

  Approximately 8 weeks

• Maximum Lesion Dimension as Observed by DBT

  Approximately 8 weeks

• Biopsy Finding of Lesions Per Subject.

  Approximately 8 weeks

Other Outcomes (1)

• Safety - Device Related Malfunctions

  less than 16 months

Study Arms (1)

DBT and FFDM

EXPERIMENTAL

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.

Device: DBT and FFDM

Interventions

DBT and FFDM DEVICE

Subjects underwent breast imaging using each device: DBT and FFDM.

Also known as: Digital Breast Tomosynthesis (3D breast imaging) and Full-Field Digital Mammography (2D breast imaging), 3D breast imaging and 2D 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);
• Initially asymptomatic women that underwent routine screening FFDM, breast ultrasound (U/S), breast magnetic resonance imaging (MRI) and/or DBT, followed by diagnostic work-up showing one of more abnormalities and referred for breast biopsy within of 30 days before study entry;
• 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.

You may not qualify if:

• Have been previously included in this study;
• 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) FFDM digital receptor without anatomical cut off during a DBT examination (or FFDM, if required);
• 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 (3)

Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute

Boca Raton, Florida, 33486, United States

Location

Cooper Health - Cooper Breast Imaging Centers

Voorhees Township, New Jersey, 08043, United States

Location

Gustave Roussy

Villejuif, 94805, France

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

Results Point of Contact

• Title: Sara Lam
• Organization: GE Healthcare

Sara.J.Lam@ge.com

1-262-548-2369

Study Officials

• Corinne Balleyguier, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

• Lydia Liao, MD

  Cooper Health

  PRINCIPAL INVESTIGATOR

• Kathy Schilling, MD

  Boca Raton Regional Hospital

  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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants underwent 2D breast imaging with Full-field digital mammography (FFDM) and by 3D breast imaging with Digital Breast Tomosynthesis (DBT).

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 24, 2014
• Study Start: March 1, 2015
• Primary Completion: August 29, 2017
• Study Completion: August 29, 2017
• Last Updated: February 26, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-02

Locations

FR (1); US (2)