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

• Sponsor: GE Healthcare (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02324205
• Collaborator: (none)
• Enrollment: 196
• Locations: 3
• Arm: 1
• Duration (Months): 30
• Patients Per Site: 65.3
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

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

Detailed Description

ADAPT program consists of 2 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 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: 196 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants underwent 2D breast imaging with Full-field digital mammography (FFDM) and by 3D breast imaging with Digital Breast Tomosynthesis (DBT).All participants underwent 2D breast imaging with Full-field digital mammography (FFDM) and by 3D breast imaging with Digital Breast Tomosynthesis (DBT).
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-BX: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Aug 29, 2017
• Actual Study Completion Date: Aug 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
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). 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; Subjects underwent breast imaging using each device: DBT and FFDM.; Other Names: Digital Breast Tomosynthesis (3D breast imaging) and Full-Field Digital Mammography (2D breast imaging) 3D breast imaging and 2D breast imaging

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. Maximum Lesion Dimension as Observed by FFDM [Approximately 8 weeks]

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

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

   Maximum length of lesions (measured in mm) when images were collected using DBT

5. Biopsy Finding of Lesions Per Subject. [Approximately 8 weeks]

   Describes histologic cancer and non-cancer findings of lesion biopsy. Cancer status of lesions was reported per subject, not per lesion.

Other Outcome Measures

1. Safety - Device Related Malfunctions [less than 16 months]

   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 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.

Exclusion Criteria:

• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute	Boca Raton	Florida	United States	33486
2	Cooper Health - Cooper Breast Imaging Centers	Voorhees	New Jersey	United States	08043
3	Gustave Roussy	Villejuif		France	94805

Sponsors and Collaborators

• GE Healthcare

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 8, 2016

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT02324205
• Other Study ID Numbers: 124.03-2014-GES-0010_2
• First Posted: Dec 24, 2014
• Last Update Posted: Feb 26, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	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). 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. DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.
Period Title: Overall Study
STARTED	196
COMPLETED	159
NOT COMPLETED	37

Baseline Characteristics

Arm/Group Title	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). 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. DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.
Overall Participants	196
Age, Customized (Count of Participants)
Age 30 years and greater	196 100%
Sex: Female, Male (Count of Participants)
Female	196 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	136 69.4%
France	60 30.6%

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

Initially asymptomatic adult women presenting for breast biopsy based on prior breast imaging.

Arm/Group Title	DBT and FFDM
Arm/Group Description	Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and 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. Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.
Measure Participants	196
Participants that completed DBT, FFDM and Biopsy	159 81.1%
Participants that did not complete all three tests	37 18.9%

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

Participants with lesions evaluated by FFDM. A single participant may have more than one lesion.

Arm/Group Title	DBT and FFDM
Arm/Group Description	Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and 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. Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.
Measure Participants	159
Measure lesions	173
Lesion description = mass	76
Lesion description = calcification	67
Lesion description = all other	30

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

Participants with DBT breast images collected, and lesion characteristic described by qualified reader. Participants may have more than one lesion.

Arm/Group Title	DBT and FFDM
Arm/Group Description	Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and 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. Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.
Measure Participants	159
Measure lesions	192
Lesion description = mass	97
Lesion description = calcification	67
Lesion description = all other	28

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Lesions observed and measured when images were collected when using FFDM; Seven (7) of the total 173 observed lesions were not measured.

Arm/Group Title	DBT and FFDM
Arm/Group Description	Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and 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. Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.
Measure Participants	159
Measure lesions	166
Mean (Standard Deviation) [millimeters (mm)]	12.45 (9.89)

5. Secondary Outcome

Title	Maximum Lesion Dimension as Observed by DBT
Description	Maximum 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. Sixteen (16) of the total 192 observed lesions were not measured.

Arm/Group Title	DBT and FFDM
Arm/Group Description	Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and 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. Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.
Measure Participants	159
Measure Lesions	176
Mean (Standard Deviation) [millimeters (mm)]	12.24 (9.09)

6. Secondary Outcome

Title	Biopsy Finding of Lesions Per Subject.
Description	Describes histologic cancer and non-cancer findings of lesion biopsy. Cancer status of lesions was reported per subject, not per lesion.
Time Frame	Approximately 8 weeks

Outcome Measure Data

Analysis Population Description

All lesions with a biopsy finding: "positive/malignant", "negative/benign" or "non-conclusive". Biopsy findings were reported per subject, not per lesion.

Arm/Group Title	DBT and FFDM
Arm/Group Description	Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and 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. Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.
Measure Participants	159
Lesions identified as "positive/malignant"	62 31.6%
Lesions identified as "negative/benign"	94 48%
Biopsy was no-conclusive	3 1.5%

7. Other Pre-specified Outcome

Title	Safety - Device Related Malfunctions
Description	Number of device-related malfunctions by imaging modality.
Time Frame	less than 16 months

Outcome Measure Data

Analysis Population Description

Number of device malfunctions recorded for either DBT or FFDM imaging.

Arm/Group Title	DBT and FFDM
Arm/Group Description	Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and 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. Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.
Measure Participants	196
Number [malfunction events reported]	0

Adverse Events

Time Frame	Adverse Event data were collected from June 2015 to November 2016 (1 year and 5 months).
Arm/Group Title	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). 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. DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.
All Cause Mortality
	DBT and FFDM
	Affected / at Risk (%)	# Events
Total	0/196 (0%)
Serious Adverse Events
	DBT and FFDM
	Affected / at Risk (%)	# Events
Total	0/196 (0%)
Other (Not Including Serious) Adverse Events
	DBT and FFDM
	Affected / at Risk (%)	# Events
Total	0/196 (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.