Clinical trial · Interventional
Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
NCT03482557CI-TRIAL-00084485completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening
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 | Device | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Contrast-Enhanced Spectral Mammography
- description
- Each enrolled participant will receive a CESM either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CESM must be performed prior to biopsy.
- interventionNames
- Device: CESM
- type
- EXPERIMENTAL
- label
- Breast MRI
- description
- Each enrolled participant will receive an 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 MRI must be performed prior to biopsy.
- interventionNames
- Device: MRI
Primary outcomes (1)
- measure
- Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.