Trial Outcomes & Findings for Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (NCT NCT02540083)

NCT ID: NCT02540083

Last Updated: 2019-02-05

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: Approximately 8 weeks
• Results posted on: 2019-02-05

Participant Flow

Participant milestones

Measure	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). DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging
Overall Study STARTED	94
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	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). DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging
Overall Study Withdrawal by Subject	16

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Experimental: DBT and FFDM n=78 Participants 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
Age, Continuous	52.8 years n=78 Participants
Sex: Female, Male Female	78 Participants n=78 Participants
Sex: Female, Male Male	0 Participants n=78 Participants
Region of Enrollment United States	78 Participants n=78 Participants

PRIMARY outcome

Timeframe: Approximately 8 weeks

Population: Total number of participants enrolled.

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	Experimental: DBT and FFDM n=94 Participants 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
Number of Participants With DBT, FFDM and Biopsy Specimens Collected Participants that completed DBT, FFDM and Biopsy	78 Participants
Number of Participants With DBT, FFDM and Biopsy Specimens Collected Participants taht did not complete all three tests	16 Participants

SECONDARY outcome

Timeframe: Approximately 8 weeks

Population: Lesions observed using FFDM imaging

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

Outcome measures

Measure	Experimental: DBT and FFDM n=107 Lesions 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
Lesion Type Observed by FFDM Imaging Lesion type = mass	43 Lesions
Lesion Type Observed by FFDM Imaging Lesion type = calcification	32 Lesions
Lesion Type Observed by FFDM Imaging Lesion type = all other	32 Lesions

SECONDARY outcome

Timeframe: Approximately 8 weeks

Population: Lesions observed using DBT

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

Outcome measures

Measure	Experimental: DBT and FFDM n=118 lesions 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
Lesion Type Observed by DBT Imaging Lesion description = mass	51 lesions
Lesion Type Observed by DBT Imaging Lesion description = calcification	33 lesions
Lesion Type Observed by DBT Imaging Lesion description = all other	34 lesions

SECONDARY outcome

Timeframe: Approximately 8 weeks

Population: Lesions as observed by FFDM

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

Outcome measures

Measure	Experimental: DBT and FFDM n=88 Lesions 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
Lesion Size as Observed by FFDM	15.3 millimeters (mm) Interval 3.0 to 80.0

SECONDARY outcome

Timeframe: Approximately 8 weeks

Population: Lesions observed and measured when images were collected using DBT

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

Outcome measures

Measure	Experimental: DBT and FFDM n=111 lesions 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
Lesion Size as Observed by DBT	13.8 millimeters (mm) Interval 1.5 to 66.0

SECONDARY outcome

Timeframe: Approximately 8 weeks

Population: All participants who completed the study.

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

Outcome measures

Measure	Experimental: DBT and FFDM n=78 Participants 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
Biopsy Finding of Lesions Lesion is "positive/malignant"	32 Participants
Biopsy Finding of Lesions Lesion is "negative/benign"	43 Participants
Biopsy Finding of Lesions Biopsy was non-conclusive	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 8 weeks

Population: All enrolled participants

Number of device-related malfunctions by imaging modality.

Outcome measures

Measure	Experimental: DBT and FFDM n=94 Participants 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
Safety - Device Related Malfunctions Device malfunctions for FFDM	0 malfunctions
Safety - Device Related Malfunctions Device malfunctions for DBT	0 malfunctions

Adverse Events

Experimental: DBT and FFDM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sara Lam

GE Healthcare

Phone: 1-262-548-2369

Email: Sara.J.Lam@ge.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place