Clinical trial · Observational
CE-MRI&CESM in Solid Breast Lesions
1.3 Role of Contrast-enhanced Mammography and Dynamic Contrast-enhanced MRI in the Assessment of Solid Breast Lesions
NCT04832191CI-TRIAL-00051049unknownClinicalTrials.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)
Our study aimed to assess the accuracy of CE-SM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CE-SM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- comparison between accuracy of CESM and CE-MRI in diagnosing breast cancer.
- timeFrame
- baseline
- description
- Measurement of sensitivity, specificity and predictive values of CESM and CE-MRI in diagnosing breast cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have previously undergone mammography (MG) and ultrasound and have a solid (BIRADs III and more) breast lesion. Exclusion Criteria: * Cystic breast lesions * BIRADs I and II breast lesions(benign) * Pregnancy * History of allergic reaction to iodinated contrast agent * Renal insufficiency * Other contraindications to MRI include pacemaker, claustrophobia or metal prosthesis.
References
Publications (2)
- BACKGROUNDZhu X, Huang JM, Zhang K, Xia LJ, Feng L, Yang P, Zhang MY, Xiao W, Lin HX, Yu YH. Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. Clin Breast Cancer. 2018 Oct;18(5):e985-e995. doi: 10.1016/j.clbc.2018.06.003. Epub 2018 Jun 15. PMID 29983379
- BACKGROUNDLi L, Roth R, Germaine P, Ren S, Lee M, Hunter K, Tinney E, Liao L. Contrast-enhanced spectral mammography (CESM) versus breast magnetic resonance imaging (MRI): A retrospective comparison in 66 breast lesions. Diagn Interv Imaging. 2017 Feb;98(2):113-123. doi: 10.1016/j.diii.2016.08.013. Epub 2016 Sep 26. PMID 27687829