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

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ClinicalTrials.gov Identifier: NCT02540083
Recruitment Status : Terminated (Sponsor has obtained sufficient case load prematurely.)
First Posted : September 3, 2015
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Breast Cancer
Tumors, Breast
Intervention Device: DBT and FFDM
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental: DBT and FFDM
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Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Period Title: Overall Study
Started 94
Completed 78
Not Completed 16
Reason Not Completed
Withdrawal by Subject             16
Arm/Group Title Experimental: DBT and FFDM
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Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Overall Number of Baseline Participants 78
Hide Baseline Analysis Population Description
Population includes study participants who completed DBT, FFDM and lesion biopsy.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 78 participants
52.8
(31 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
78
 100.0%
Male
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 78 participants
78
 100.0%
1.Primary Outcome
Title Number of Participants With DBT, FFDM and Biopsy Specimens Collected
Hide Description For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.
Time Frame Approximately 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of participants enrolled.
Arm/Group Title Experimental: DBT and FFDM
Hide Arm/Group Description:

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Overall Number of Participants Analyzed 94
Measure Type: Count of Participants
Unit of Measure: Participants
Participants that completed DBT, FFDM and Biopsy
78
  83.0%
Participants taht did not complete all three tests
16
  17.0%
2.Secondary Outcome
Title Lesion Type Observed by FFDM Imaging
Hide Description Lesions were characterized based on findings identified during image evaluations performed by qualified readers.
Time Frame Approximately 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Lesions observed using FFDM imaging
Arm/Group Title Experimental: DBT and FFDM
Hide Arm/Group Description:

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Overall Number of Participants Analyzed 78
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
107
Count of Units
Unit of Measure: Lesions
Lesion type = mass
43
  40.2%
Lesion type = calcification
32
  29.9%
Lesion type = all other
32
  29.9%
3.Secondary Outcome
Title Lesion Type Observed by DBT Imaging
Hide Description Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.
Time Frame Approximately 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Lesions observed using DBT
Arm/Group Title Experimental: DBT and FFDM
Hide Arm/Group Description:

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Overall Number of Participants Analyzed 78
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
118
Count of Units
Unit of Measure: lesions
Lesion description = mass
51
  43.2%
Lesion description = calcification
33
  28.0%
Lesion description = all other
34
  28.8%
4.Secondary Outcome
Title Lesion Size as Observed by FFDM
Hide Description Length of Lesions (measured in mm) when images were collected using FFDM.
Time Frame Approximately 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Lesions as observed by FFDM
Arm/Group Title Experimental: DBT and FFDM
Hide Arm/Group Description:

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Overall Number of Participants Analyzed 78
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
88
Mean (Full Range)
Unit of Measure: millimeters (mm)
15.3
(3.0 to 80.0)
5.Secondary Outcome
Title Lesion Size as Observed by DBT
Hide Description Length of lesions (measured in mm) when images were collected using DBT.
Time Frame Approximately 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Lesions observed and measured when images were collected using DBT
Arm/Group Title Experimental: DBT and FFDM
Hide Arm/Group Description:

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Overall Number of Participants Analyzed 78
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
111
Mean (Full Range)
Unit of Measure: millimeters (mm)
13.8
(1.5 to 66.0)
6.Secondary Outcome
Title Biopsy Finding of Lesions
Hide Description Describes histologic cancer and non-cancer findings of lesion biopsy.
Time Frame Approximately 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study.
Arm/Group Title Experimental: DBT and FFDM
Hide Arm/Group Description:

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Lesion is "positive/malignant"
32
  41.0%
Lesion is "negative/benign"
43
  55.1%
Biopsy was non-conclusive
3
   3.8%
7.Other Pre-specified Outcome
Title Safety - Device Related Malfunctions
Hide Description Number of device-related malfunctions by imaging modality.
Time Frame Approximately 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Experimental: DBT and FFDM
Hide Arm/Group Description:

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: malfunctions
Device malfunctions for FFDM 0
Device malfunctions for DBT 0
Time Frame AE data was collected for each subject for the duration that they were on site for DBT or FFDM scans. For all subjects, duration of study was approximately 21 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: DBT and FFDM
Hide Arm/Group Description

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

All-Cause Mortality
Experimental: DBT and FFDM
Affected / at Risk (%)
Total   0/94 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental: DBT and FFDM
Affected / at Risk (%)
Total   0/94 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental: DBT and FFDM
Affected / at Risk (%)
Total   0/94 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sara Lam
Organization: GE Healthcare
Phone: 1-262-548-2369
EMail: Sara.J.Lam@ge.com
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02540083     History of Changes
Other Study ID Numbers: 124.03-2015-GES-0001
First Submitted: September 1, 2015
First Posted: September 3, 2015
Results First Submitted: January 4, 2019
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019