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

• Sponsor: GE Healthcare (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02540083
• Collaborator: (none)
• Enrollment: 94
• Locations: 2
• Arm: 1
• Actual Duration (Months): 21.9
• Patients Per Site: 47
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Tumors, Breast	Device: DBT and FFDM	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 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
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: May 30, 2017
• Actual Study Completion Date: May 30, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With DBT, FFDM and Biopsy Specimens Collected [Approximately 8 weeks]

   For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.

Secondary Outcome Measures

1. Lesion Type Observed by FFDM Imaging [Approximately 8 weeks]

   Lesions were characterized based on findings identified during image evaluations performed by qualified readers.

2. Lesion Type Observed by DBT Imaging [Approximately 8 weeks]

   Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.

3. Lesion Size as Observed by FFDM [Approximately 8 weeks]

   Length of Lesions (measured in mm) when images were collected using FFDM.

4. Lesion Size as Observed by DBT [Approximately 8 weeks]

   Length of lesions (measured in mm) when images were collected using DBT.

5. Biopsy Finding of Lesions [Approximately 8 weeks]

   Describes histologic cancer and non-cancer findings of lesion biopsy.

Other Outcome Measures

1. Safety - Device Related Malfunctions [Approximately 8 weeks]

   Number of device-related malfunctions by imaging modality.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolina Breast Imaging Specialists	Greenville	North Carolina	United States	27834
2	Avera Breast Center	Sioux Falls	South Dakota	United States	57105

Sponsors and Collaborators

• GE Healthcare

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 23, 2016

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT02540083
• Other Study ID Numbers: 124.03-2015-GES-0001
• First Posted: Sep 3, 2015
• Last Update Posted: Feb 5, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Experimental: DBT and FFDM
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
Period Title: Overall Study
STARTED	94
COMPLETED	78
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Experimental: DBT and FFDM
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 Participants	78
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	52.8
Sex: Female, Male (Count of Participants)
Female	78 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	78 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With DBT, FFDM and Biopsy Specimens Collected
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

Outcome Measure Data

Analysis Population Description

Total number of participants enrolled.

Arm/Group Title	Experimental: DBT and FFDM
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
Measure Participants	94
Participants that completed DBT, FFDM and Biopsy	78 100%
Participants taht did not complete all three tests	16 20.5%

2. Secondary Outcome

Title	Lesion Type Observed by FFDM Imaging
Description	Lesions were characterized based on findings identified during image evaluations performed by qualified readers.
Time Frame	Approximately 8 weeks

Outcome Measure Data

Analysis Population Description

Lesions observed using FFDM imaging

Arm/Group Title	Experimental: DBT and FFDM
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
Measure Participants	78
Measure Lesions	107
Lesion type = mass	43
Lesion type = calcification	32
Lesion type = all other	32

3. Secondary Outcome

Title	Lesion Type Observed by DBT Imaging
Description	Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.
Time Frame	Approximately 8 weeks

Outcome Measure Data

Analysis Population Description

Lesions observed using DBT

Arm/Group Title	Experimental: DBT and FFDM
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
Measure Participants	78
Measure lesions	118
Lesion description = mass	51
Lesion description = calcification	33
Lesion description = all other	34

4. Secondary Outcome

Title	Lesion Size as Observed by FFDM
Description	Length of Lesions (measured in mm) when images were collected using FFDM.
Time Frame	Approximately 8 weeks

Outcome Measure Data

Analysis Population Description

Lesions as observed by FFDM

Arm/Group Title	Experimental: DBT and FFDM
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
Measure Participants	78
Measure Lesions	88
Mean (Full Range) [millimeters (mm)]	15.3

5. Secondary Outcome

Title	Lesion Size as Observed by DBT
Description	Length of lesions (measured in mm) when images were collected using DBT.
Time Frame	Approximately 8 weeks

Outcome Measure Data

Analysis Population Description

Lesions observed and measured when images were collected using DBT

Arm/Group Title	Experimental: DBT and FFDM
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
Measure Participants	78
Measure lesions	111
Mean (Full Range) [millimeters (mm)]	13.8

6. Secondary Outcome

Title	Biopsy Finding of Lesions
Description	Describes histologic cancer and non-cancer findings of lesion biopsy.
Time Frame	Approximately 8 weeks

Outcome Measure Data

Analysis Population Description

All participants who completed the study.

Arm/Group Title	Experimental: DBT and FFDM
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
Measure Participants	78
Lesion is "positive/malignant"	32 41%
Lesion is "negative/benign"	43 55.1%
Biopsy was non-conclusive	3 3.8%

7. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled participants

Arm/Group Title	Experimental: DBT and FFDM
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
Measure Participants	94
Device malfunctions for FFDM	0
Device malfunctions for DBT	0

Adverse Events

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.
Arm/Group Title	Experimental: DBT and FFDM
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 (%)	# Events
Total	0/94 (0%)
Serious Adverse Events
	Experimental: DBT and FFDM
	Affected / at Risk (%)	# Events
Total	0/94 (0%)
Other (Not Including Serious) Adverse Events
	Experimental: DBT and FFDM
	Affected / at Risk (%)	# Events
Total	0/94 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.