Clinical trial · Interventional
Contrast-Enhanced Spectral Mammography (CESM)
The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer
NCT06311695CI-TRIAL-00078156CESMunknownPhase 2ClinicalTrials.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)
The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced Mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast Enhanced Mammography
- description
- Patients underwent Contrast Enhanced Mammography
- interventionNames
- Device: Contrast Enhanced Mammography
Primary outcomes (1)
- measure
- Evaluation of negative predictive value (NPV) of the CEM
- timeFrame
- 1 month
- description
- Assessment of diagnostic accuracy of CEM in dense breasts considering as reference the classification obtained with VABB. Negative predictive value will be expressed as the proportion of patients classified as having no evidence of disease or Ductal Carcinoma In Situ (DCIS) at surgery among all patients with absence of contrast uptake at CEM
Secondary outcomes (3)
- measure
- Evaluation of sensitivity of CEM
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with breast lesions, who underwent bilateral CEM * Histological assessment Exclusion Criteria: * The subject is known to have risks of adverse effects with iodine contrast agents * The subject has breasts too large to be adequately positioned on Full field digital mammography (FFDM) digital receptor without anatomical cut off during an FFDM examination
References
Publications (0)
Data not yet available
No reference posted for this study.