Evaluation of the use of contrast agent in mammography to improve the specificity of breast cancer diagnosis

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)? - IEO 960

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000326-22-IT

Enrollment

170

Registered

2020-10-21

Start date

2020-09-22

Completion date

Unknown

Last updated

2024-12-03

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 MedDRA version: 20.0 Level: PT Classification code 10061021 Term: Breast disorder System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: ULTRAVIST - 370 MG/ML SOLUZIONE INIETTABILE 1 FLACONE 100 ML Product Name: ULTRAVIST 370 mg/ml Product Code: [ULTRAVIST 370 mg/ml] Pharmaceutical Form: Solution for injection INN or Propos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Woman with suspicious breast lesions from FFDM, US and/or MR imaging and for whom a presurgical evaluation is recommended • The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: • The subject is known to have risks of adverse effects with iodine contrast agents. • The subject is asymptomatic and without suspicious findings from routine imaging. • The subject is participating or has participated (within the prior 30 days) in another clinical

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the role of Contrast-Enhanced Spectral Mammography in the diagnostic workup of breast cancer;Secondary Objective: To evaluate CESM diagnostic performance in suspicious breast lesions;Primary end point(s): To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery);Timepoint(s) of evaluation of this end point: 2 months in surgery, 2-3 years in case of follow up	—

Measure

Time frame

Main Objective: To evaluate the role of Contrast-Enhanced Spectral Mammography in the diagnostic workup of breast cancer;Secondary Objective: To evaluate CESM diagnostic performance in suspicious breast lesions;Primary end point(s): To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery);Timepoint(s) of evaluation of this end point: 2 months in surgery, 2-3 years in case of follow up

—

Secondary

Measure	Time frame
Secondary end point(s): 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).;Timepoint(s) of evaluation of this end point: 2 months in surgery, 2-3 years in case of follow up	—

Countries

Italy

Contacts

Public ContactUfficio Studi Clinici e Attività Re

Istituto Europeo di Oncologia

ufficio.studiclinici@ieo.it0257489848

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026