The role of Contrast-Enhanced Spectral Mammography (CESM) in the diagnostic process of breast cancer: can it improve specificity of first-line examinations and therefore reduce the suspicious lesions that undergo vacuum assisted breast biopsy (VABB)?

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517486-16-00

Acronym

IEO 960

Enrollment

468

Registered

2024-10-14

Start date

2020-09-30

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with breast lesions undergoing further examination

Brief summary

To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery)

Detailed description

To establish CESM diagnostic performance in suspicious breast lesions using histology from VABB as gold standard correlating the definite result (after surgery) with preoperative imaging (accuracy).

Interventions

DRUGUltravist 370 mg/ml soluzione iniettabile

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery)	—

Secondary

Measure	Time frame
To establish CESM diagnostic performance in suspicious breast lesions using histology from VABB as gold standard correlating the definite result (after surgery) with preoperative imaging (accuracy).	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026