Trial Outcomes & Findings for Screening Contrast-Enhanced Mammography as an Alternative to MRI (NCT NCT04764292)

Last Updated: 2026-05-22

Results Overview

Cancer detection rate per 1,000 screenings with CEM compared to standard mammography/tomosynthesis (DBT) alone. Interpretation and performance outcomes from the primary reader were compared between standard-of-care DBT examinations interpreted alone and DBT examinations interpreted with the addition of CEM.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

615 participants

Primary outcome timeframe

1.5 years

Results posted on

2026-05-22

Participant Flow

All participants who signed informed consent were assigned to a single screening contrast enhanced mammography (CEM) examination with clinical standard-of-care tomosynthesis (DBT).Two radiologists (one primary) evaluated each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order, initially blinded to the other modality.

Participant milestones

Participant milestones
Measure	Contrast-enhanced Mammography Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography (CEM). Women will also have standard-of-care mammography/tomosynthesis (DBT) per usual clinical practice.
Overall Study STARTED	615
Overall Study Contrast enhanced mammography	615
Overall Study Standard Mammography/Tomosynthesis	615
Overall Study COMPLETED	601
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Contrast-enhanced Mammography Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography (CEM). Women will also have standard-of-care mammography/tomosynthesis (DBT) per usual clinical practice.
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	13

Baseline Characteristics

Screening Contrast-Enhanced Mammography as an Alternative to MRI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contrast-enhanced Mammography n=601 Participants Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.
Age, Continuous	57 Years n=2 Participants
Sex: Female, Male Female	601 Participants n=2 Participants
Sex: Female, Male Male	0 Participants n=2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2 Participants
Race (NIH/OMB) Asian	9 Participants n=2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=2 Participants
Race (NIH/OMB) Black or African American	20 Participants n=2 Participants
Race (NIH/OMB) White	570 Participants n=2 Participants
Race (NIH/OMB) More than one race	1 Participants n=2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	601 Participants n=2 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants
Breast Density Fatty	0 Participants n=2 Participants
Breast Density Scattered	77 Participants n=2 Participants
Breast Density Heterogeneously dense	473 Participants n=2 Participants
Breast Density Extremely dense	51 Participants n=2 Participants
Menopausal status Premenopausal	100 Participants n=2 Participants
Menopausal status Perimenopausal	101 Participants n=2 Participants
Menopausal status Postmenopausal	400 Participants n=2 Participants
Body Mass Index 25 kg/m^2 or less	325 Participants n=2 Participants
Body Mass Index > 25 to 30 kg/m^2	159 Participants n=2 Participants
Body Mass Index > 30 kg/m^2	117 Participants n=2 Participants

PRIMARY outcome

Timeframe: 1.5 years

Outcome measures

Outcome measures
Measure	Digital Breast Tomosynthesis (DBT) n=601 Participants All women received both 3D mammography (DBT) and contrast-enhanced mammography (CEM) for breast cancer screening. This group looks at the cancer detection rate per 1,000 screenings for DBT alone for the primary reader/observer.	DBT and Contrast-enhanced Mammography n=601 Participants All women received both 3D mammography (DBT) and contrast-enhanced mammography (CEM) for breast cancer screening. This group looks at the cancer detection rate per 1,000 screenings for DBT plus CEM for the primary reader/observer.
Cancer Detection Rate (CDR) Per 1,000 Screenings	8.3 CDR per 1,000 screenings Interval 2.7 to 19.3	18.3 CDR per 1,000 screenings Interval 9.2 to 32.5

SECONDARY outcome

Timeframe: 1.5 years

Population: Number of participants without cancer, i.e., true negatives (TN)

To assess changes in false positive recall rates from CEM. DBT false-positive findings for primary observer (usual care) vs DBT and CEM false positive findings for primary observer

Outcome measures

Outcome measures
Measure	Digital Breast Tomosynthesis (DBT) n=589 Participants All women received both 3D mammography (DBT) and contrast-enhanced mammography (CEM) for breast cancer screening. This group looks at the cancer detection rate per 1,000 screenings for DBT alone for the primary reader/observer.	DBT and Contrast-enhanced Mammography n=589 Participants All women received both 3D mammography (DBT) and contrast-enhanced mammography (CEM) for breast cancer screening. This group looks at the cancer detection rate per 1,000 screenings for DBT plus CEM for the primary reader/observer.
False Positive Recall Rates	8.1 percent recalled without cancer Interval 6.1 to 10.7	21.6 percent recalled without cancer Interval 18.3 to 25.1

SECONDARY outcome

Timeframe: 1.5 years

To assess changes in the biopsy rate after the addition of CEM. DBT biopsy rate for primary observer (usual care) vs DBT and CEM biopsy rate for primary observer.

Outcome measures

Outcome measures
Measure	Digital Breast Tomosynthesis (DBT) n=601 Participants All women received both 3D mammography (DBT) and contrast-enhanced mammography (CEM) for breast cancer screening. This group looks at the cancer detection rate per 1,000 screenings for DBT alone for the primary reader/observer.	DBT and Contrast-enhanced Mammography n=601 Participants All women received both 3D mammography (DBT) and contrast-enhanced mammography (CEM) for breast cancer screening. This group looks at the cancer detection rate per 1,000 screenings for DBT plus CEM for the primary reader/observer.
Biopsy Rate	3.0 percentage of participants biopsied Interval 1.8 to 4.7	11.5 percentage of participants biopsied Interval 9.0 to 14.3

SECONDARY outcome

Timeframe: 1.5 years

Population: Number of participants recalled for each arm

To assess changes in positive predictive value of recall (PPV1) after the addition of CEM. DBT PPV1for primary observer (usual care) vs DBT and CEM PPV1 for primary observer.

Outcome measures

Outcome measures
Measure	Digital Breast Tomosynthesis (DBT) n=58 Participants All women received both 3D mammography (DBT) and contrast-enhanced mammography (CEM) for breast cancer screening. This group looks at the cancer detection rate per 1,000 screenings for DBT alone for the primary reader/observer.	DBT and Contrast-enhanced Mammography n=138 Participants All women received both 3D mammography (DBT) and contrast-enhanced mammography (CEM) for breast cancer screening. This group looks at the cancer detection rate per 1,000 screenings for DBT plus CEM for the primary reader/observer.
Positive Predictive Value of Recall (PPV1)	9.4 percentage with a positive biopsy Interval 3.1 to 20.7	8.0 percentage with a positive biopsy Interval 4.0 to 13.8

Adverse Events

Contrast-enhanced Mammography

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Standard Mammography/Tomosynthesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Contrast-enhanced Mammography n=615 participants at risk Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.	Standard Mammography/Tomosynthesis n=615 participants at risk Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.
Skin and subcutaneous tissue disorders IV infiltrate	0.16% 1/615 • 1.5 years All participants were assigned to screening contrast enhanced mammography (CEM) with standard of care tomosynthesis (DBT).	0.00% 0/615 • 1.5 years All participants were assigned to screening contrast enhanced mammography (CEM) with standard of care tomosynthesis (DBT).
Skin and subcutaneous tissue disorders contrast reaction	0.65% 4/615 • 1.5 years All participants were assigned to screening contrast enhanced mammography (CEM) with standard of care tomosynthesis (DBT).	0.00% 0/615 • 1.5 years All participants were assigned to screening contrast enhanced mammography (CEM) with standard of care tomosynthesis (DBT).

Additional Information

Dr. Wendie A. Berg

University of Pittsburgh

Phone: 412-641-1635

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place