N/A
Completed N=132
Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
Source: ClinicalTrials.gov NCT03482557 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening — 0.91; .91 Probability of malignancy
Summary
This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening |
0.91; .91 | — |
| SECONDARY Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening |
.906; .894 | — |
| SECONDARY Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening |
.906; .788 | — |
Eligibility Criteria
Inclusion Criteria
- CESM and MRI exam performed within 3 months of one another.
- CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
- CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
- MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted
Exclusion Criteria
- Imaging sets with implants.
- Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
- Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available
Data sourced from ClinicalTrials.gov (NCT03482557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.