Clinical trial · Interventional
Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer
Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI
NCT02275871CI-TRIAL-00044027terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Didn't have funding to support the study design
Summary
Brief summary (as posted)
This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CESM | Other | — | UNRESOLVED |
| MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI and CESM
- description
- High risk patients will get standard of care screening MRI and study CESM on the same day.
- interventionNames
- Other: MRI
- Other: CESM
Primary outcomes (1)
- measure
- Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity
- timeFrame
- 4 years
- description
- All CESM and MRI cases will be evaluated for the presence or absence of malignancy and will be coded to reflect this interpretation. Breast imaging-reporting and data system (BIRADS) scores of 1-3 represent the absence of malignancy and BIRADS code of 4-5 represent the presence of malignancy. These cases will be compared to the truth of whether malignancy developed in the patient based on biopsy results and long term clinical follow-up (2 years).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Women * Age \> or equal to 30 years * High risk (\>20% lifetime risk) * Has a bilateral mammogram within the last 7 months * Has had a same day high risk screening MRI Exclusion Criteria: * Participants who have a known allergy or contraindication to iodinated contrast. * Participants who have a known allergy to food or medications. * Participants who have renal insufficiency or failure. * Participants who are pregnant or breastfeeding. * Participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
References
Publications (0)
Data not yet available
No reference posted for this study.