Trial Outcomes & Findings for Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening (NCT NCT03482557)
NCT ID: NCT03482557
Last Updated: 2025-01-09
Results Overview
We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.
COMPLETED
NA
132 participants
2 years
2025-01-09
Participant Flow
132
132 patients were included in the reader study. 42 patients had imaging acquired as part of clinical trial NCT02275871, 78 as part of clinical trial NCT03482557, and 12 as part of clinical care.
Participant milestones
| Measure |
Screening CESM and MRI
Each enrolled participant will receive both a CESM and MRI exam either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CEM and MRI must be performed prior to biopsy.
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|---|---|
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Overall Study
STARTED
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132
|
|
Overall Study
COMPLETED
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132
|
|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Screening CESM and Breast MRI
n=132 Participants
Each enrolled participant will receive both a CESM and MRI exam either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CEM and MRI must be performed prior to biopsy.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=132 Participants
|
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Age, Categorical
Between 18 and 65 years
|
116 Participants
n=132 Participants
|
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Age, Categorical
>=65 years
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16 Participants
n=132 Participants
|
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Age, Continuous
|
54 years
n=132 Participants
|
|
Sex: Female, Male
Female
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132 Participants
n=132 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=132 Participants
|
|
Region of Enrollment
United States
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132 Participants
n=132 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.
We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.
Outcome measures
| Measure |
Cancers Identified With CESM
n=132 Participants
Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI
|
Cancers Identified With Screening MRI
n=132 Participants
Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI
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|---|---|---|
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Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening
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0.91 Probability of malignancy
Interval 0.885 to 0.926
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.91 Probability of malignancy
Interval 0.894 to 0.925
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SECONDARY outcome
Timeframe: 2 yearsPopulation: Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.
Radiologist readers evaluated CEM and abbreviated MRI in 132 patients, some who had cancer and some who did not. The area under the curve was determine for each reader for each exam type.
Outcome measures
| Measure |
Cancers Identified With CESM
n=132 Participants
Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI
|
Cancers Identified With Screening MRI
n=132 Participants
Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI
|
|---|---|---|
|
Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening
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.906 Probability of malignancy
Interval 0.885 to 0.926
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.894 Probability of malignancy
Interval 0.859 to 0.929
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SECONDARY outcome
Timeframe: 2 yearsPopulation: Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.
We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.
Outcome measures
| Measure |
Cancers Identified With CESM
n=132 Participants
Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI
|
Cancers Identified With Screening MRI
n=132 Participants
Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI
|
|---|---|---|
|
Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening
|
.906 Probability of malignancy
Interval 0.885 to 0.926
|
.788 Probability of malignancy
Interval 0.756 to 0.82
|
Adverse Events
Screening CESM Before Biopsy
Screening MRI Before Biopsy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place