Trial Outcomes & Findings for Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT) (NCT NCT02324205)
NCT ID: NCT02324205
Last Updated: 2019-02-26
Results Overview
For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.
TERMINATED
NA
196 participants
Approximately 8 weeks
2019-02-26
Participant Flow
Participant milestones
| Measure |
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.
DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.
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|---|---|
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Overall Study
STARTED
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196
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Overall Study
COMPLETED
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159
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Overall Study
NOT COMPLETED
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37
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Reasons for withdrawal
| Measure |
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.
DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.
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|---|---|
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Overall Study
Withdrawal by Subject
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37
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DBT and FFDM
n=196 Participants
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.
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Age, Customized
Age 30 years and greater
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196 Participants
n=196 Participants
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Sex: Female, Male
Female
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196 Participants
n=196 Participants
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Sex: Female, Male
Male
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0 Participants
n=196 Participants
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Region of Enrollment
United States
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136 Participants
n=196 Participants
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Region of Enrollment
France
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60 Participants
n=196 Participants
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PRIMARY outcome
Timeframe: Approximately 8 weeksPopulation: Initially asymptomatic adult women presenting for breast biopsy based on prior breast imaging.
For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.
Outcome measures
| Measure |
DBT and FFDM
n=196 Participants
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.
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Number of Participants With DBT, FFDM and Biopsy Specimens Collected.
Participants that completed DBT, FFDM and Biopsy
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159 Participants
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Number of Participants With DBT, FFDM and Biopsy Specimens Collected.
Participants that did not complete all three tests
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37 Participants
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SECONDARY outcome
Timeframe: Approximately 8 weeksPopulation: Participants with lesions evaluated by FFDM. A single participant may have more than one lesion.
Lesions were characterized based on findings identified during image evaluations performed by qualified readers.
Outcome measures
| Measure |
DBT and FFDM
n=173 lesions
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.
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Lesion Type Observed by FFDM Imaging
Lesion description = mass
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76 lesions
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Lesion Type Observed by FFDM Imaging
Lesion description = calcification
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67 lesions
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Lesion Type Observed by FFDM Imaging
Lesion description = all other
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30 lesions
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SECONDARY outcome
Timeframe: Approximately 8 weeksPopulation: Participants with DBT breast images collected, and lesion characteristic described by qualified reader. Participants may have more than one lesion.
Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.
Outcome measures
| Measure |
DBT and FFDM
n=192 lesions
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.
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Lesion Type Observed by DBT Imaging
Lesion description = mass
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97 lesions
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Lesion Type Observed by DBT Imaging
Lesion description = calcification
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67 lesions
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Lesion Type Observed by DBT Imaging
Lesion description = all other
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28 lesions
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SECONDARY outcome
Timeframe: Approximately 8 weeksPopulation: Lesions observed and measured when images were collected when using FFDM; Seven (7) of the total 173 observed lesions were not measured.
Maximum Length of Lesions (measured in mm) when images were collected using FFDM.
Outcome measures
| Measure |
DBT and FFDM
n=166 lesions
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.
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Maximum Lesion Dimension as Observed by FFDM
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12.45 millimeters (mm)
Standard Deviation 9.89
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SECONDARY outcome
Timeframe: Approximately 8 weeksPopulation: Lesions observed and measured when images were collected using DBT. Sixteen (16) of the total 192 observed lesions were not measured.
Maximum length of lesions (measured in mm) when images were collected using DBT
Outcome measures
| Measure |
DBT and FFDM
n=176 Lesions
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.
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Maximum Lesion Dimension as Observed by DBT
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12.24 millimeters (mm)
Standard Deviation 9.09
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SECONDARY outcome
Timeframe: Approximately 8 weeksPopulation: All lesions with a biopsy finding: "positive/malignant", "negative/benign" or "non-conclusive". Biopsy findings were reported per subject, not per lesion.
Describes histologic cancer and non-cancer findings of lesion biopsy. Cancer status of lesions was reported per subject, not per lesion.
Outcome measures
| Measure |
DBT and FFDM
n=159 Participants
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.
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Biopsy Finding of Lesions Per Subject.
Lesions identified as "positive/malignant"
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62 participants
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Biopsy Finding of Lesions Per Subject.
Lesions identified as "negative/benign"
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94 participants
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Biopsy Finding of Lesions Per Subject.
Biopsy was no-conclusive
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3 participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: less than 16 monthsPopulation: Number of device malfunctions recorded for either DBT or FFDM imaging.
Number of device-related malfunctions by imaging modality.
Outcome measures
| Measure |
DBT and FFDM
n=196 Participants
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.
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Safety - Device Related Malfunctions
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0 malfunction events reported
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Adverse Events
DBT and FFDM
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place