NCT02540083

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

September 1, 2015

Results QC Date

January 4, 2019

Last Update Submit

February 1, 2019

Conditions

Breast CancerTumors, 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

  • Lesion Size as Observed by FFDM

    Approximately 8 weeks

  • Lesion Size as Observed by DBT

    Approximately 8 weeks

  • Biopsy Finding of Lesions

    Approximately 8 weeks

Other Outcomes (1)

  • Safety - Device Related Malfunctions

    Approximately 8 weeks

Study Arms (1)

Experimental: 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).

Device: DBT and FFDM

Interventions

DBT and FFDMDEVICE

Subjects underwent FFDM breast imaging followed by DBT breast imaging

Also known as: Digital Breast Tomosynthesis (3D breast imaging) DBT, Full-Field Digital Mammography (2D breast imaging) FFDM
Experimental: DBT and FFDM

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carolina Breast Imaging Specialists

Greenville, North Carolina, 27834, United States

Location

Avera Breast Center

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Sara Lam
Organization
GE Healthcare
Sara.J.Lam@ge.com
1-262-548-2369

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

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 3, 2015

Study Start

August 1, 2015

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

February 5, 2019

Results First Posted

February 5, 2019

Record last verified: 2019-02

Locations

US(2)