Trial Outcomes & Findings for Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography (NCT NCT01669148)

NCT ID: NCT01669148

Last Updated: 2017-06-14

Results Overview

Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 496 participants
• Primary outcome timeframe: up to two years follow up for development of breast cancer
• Results posted on: 2017-06-14

Participant Flow

496 enrolled and 426 completed study, but no information available to distinguish study arms: 1. Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown). 2. Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown).

Participant milestones

Measure	All Study Participants All participants enrolled in study
Overall Study STARTED	496
Overall Study COMPLETED	426
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Baseline characteristics by cohort

Measure	All Study Participants n=496 Participants All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	427 Participants n=5 Participants
Age, Categorical >=65 years	69 Participants n=5 Participants
Sex: Female, Male Female	496 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	248 participants n=5 Participants

PRIMARY outcome

Timeframe: up to two years follow up for development of breast cancer

Population: PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.

Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):

Sensitivity = TP / (TP+FN)

Outcome measures

Outcome data not reported

Adverse Events

All Study Participants

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

Thomas J. Brady, MD

Massachusetts General Hospital

Phone: 6177268294

Email: tbrady@mgh.harvard.edu

Results disclosure agreements

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