Trial Outcomes & Findings for Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography (NCT NCT02995980)

Results Overview

•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

1 year

Results posted on

2019-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Contrast Enhanced Mammography vs Standard Digital Mammograpm Contrast-enhanced spectral mammography for the detection breast cancer . Dual-Energy Contrast-Enhanced (DECE) mammography: Contrast mammography
Overall Study STARTED	128
Overall Study COMPLETED	114
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Contrast Enhanced Mammography vs Standard Digital Mammograpm Contrast-enhanced spectral mammography for the detection breast cancer . Dual-Energy Contrast-Enhanced (DECE) mammography: Contrast mammography
Overall Study Lost to Follow-up	14

Baseline Characteristics

Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contrast Enhanced Mammography vs Standard Digital Mammograpm n=128 Participants Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Consented 128 patients, 114 patients completed both mammograms

•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).

Outcome measures

Outcome measures
Measure	Contrast Enhanced Mammography n=114 Participants Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography	Standard Digital Mammogram n=114 Participants Full field digital mammography for the detection breast cancer digital mammography: routine digital mammography
Percent Accuracy of Contrast Mammography	100 percentage of accuracy Interval 29.0 to 100.0	67 percentage of accuracy Interval 9.0 to 99.0

PRIMARY outcome

Timeframe: 1 year

Population: Consented 128 patients, 114 patients completed both mammograms

•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).

Outcome measures

Outcome measures
Measure	Contrast Enhanced Mammography n=114 Participants Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography	Standard Digital Mammogram n=114 Participants Full field digital mammography for the detection breast cancer digital mammography: routine digital mammography
Number of Participants With Cancer Detected	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Consented 128 patients, 114 patients completed both mammograms

•The patients identified for additional imaging based on unconfirmed findings.

Outcome measures

Outcome measures
Measure	Contrast Enhanced Mammography n=114 Participants Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography	Standard Digital Mammogram n=114 Participants Full field digital mammography for the detection breast cancer digital mammography: routine digital mammography
Number of Call Backs With Contrast Mammography	10 percentage of participants Interval 5.0 to 17.0	11 percentage of participants Interval 6.0 to 19.0

Adverse Events

Contrast Enhanced Mammography vs Standard Digital Mammograpm

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

Rachael Lancaster, MD

University of Alabama at Birmingahm

Phone: 205-934-4080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place