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

Phase 1

• Conditions: Patients with breast lesions undergoing further examination; MedDRA version: 20.0Level: PTClassification code 10061021Term: Breast disorderSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000326-22-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 170

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified