Clinical trial · Observational
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization
NCT06846814CI-TRIAL-00086482enrolling by invitationClinicalTrials.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 study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.
Conditions
Conditions (2)
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 Detection | — | UNRESOLVED | — |
| Breast Cancer Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CEM protocol | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detection Rate of Additional Lesions on CEM
- timeFrame
- Within 12 months of imaging assessment.
- description
- This measure evaluates the number of additional lesions identified on Contrast-Enhanced Mammography (CEM) that require further assessment through second-look ultrasound or biopsy.
Secondary outcomes (2)
- measure
- Concordance Between Imaging Findings and Histopathology
- timeFrame
- Up to 3 months post-biopsy.
- description
- This measure assesses the percentage of biopsied lesions in which imaging findings (from CEM and SLUS) correlate with the histopathological results
- measure
- Concordance Between Imaging Findings and Follow-Up Imaging
- timeFrame
- 6-12 months after the initial CEM examination
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Patients undergoing contrast-enhanced mammography for diagnostic or surveillance purposes. * Identification of additional lesions on CEM requiring further evaluation. * Ability to provide informed consent. EXCLUSION CRITERIA: * Known breast cancer diagnosis without suspicion of additional lesions. * Contraindications to ultrasound or contrast agents. * Patients with incomplete imaging data.
References
Publications (0)
Data not yet available
No reference posted for this study.