Trial Outcomes & Findings for Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging (NCT NCT01373671)

Results Overview

The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

764 participants

Primary outcome timeframe

1 year

Results posted on

2020-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Mammography Exam Siemens DBT scan SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan
Overall Study STARTED	764
Overall Study COMPLETED	672
Overall Study NOT COMPLETED	92

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mammography Exam n=764 Participants Siemens DBT scan SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan
Age, Customized >= 40 years old	752 participants n=5 Participants
Age, Customized >= 30 years old < 40	12 participants n=5 Participants
Sex/Gender, Customized Female	764 Participants n=5 Participants
Region of Enrollment United States	764 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Per protocol 300 subjects were selected for analysis based on 89% power \& 5% type one error rate determination.

The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.

Outcome measures

Outcome measures
Measure	FFDM and DBT n=490 breasts FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration	FFDM Only n=490 breasts FFDM exam only
Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone	0.8527 unitless Standard Error 0.0268	0.7516 unitless Standard Error 0.0281

Adverse Events

Mammography Exam

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mammography Exam n=764 participants at risk Siemens DBT scan SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan
Respiratory, thoracic and mediastinal disorders Pneumonia	0.13% 1/764 • 1 year
Reproductive system and breast disorders Ovarian cancer	0.13% 1/764 • 1 year

Other adverse events

Other adverse events
Measure	Mammography Exam n=764 participants at risk Siemens DBT scan SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan
General disorders Lightheadedness	0.13% 1/764 • 1 year

Additional Information

Director of Clinical Affairs

Siemens Medical Solutions USA, Inc.

Phone: 610-448-6468

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60