Role of contrast enhanced mammography with Iomeprol 400 mgI/ml (Iomeron, Bracco), in the identification of breast cancer: I3-MaC Study

Phase 1

Conditions: Breast cancer
MedDRA version: 21.1Level: PTClassification code: 10057654Term: Breast cancer female Class: 100000004864
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: CTIS2024-513251-32-00

Lead Sponsor: Azienda Ospedaliero-Universitaria Policlinico Umberto I

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 173

Inclusion Criteria

• Female patients = 35 years of age • Patients who underwent mammography during the 5 weeks prior to enrollment in the study • Patients with a breast lesion requiring further assessment with biopsy ? BIRADS 4 or 5 breast lesion seen at mammography ? Suspicion of malignancy of a lesion seen at ultrasound and not evaluable with mammography • Patients who provide their written informed consent and are willing to comply with protocol requirements

Exclusion Criteria

• Renal insufficiency (eGFR below 30 mL/min using the MDRD equation [MDRD=Modification of Diet in Renal Disease]) • Allergy to iodinated contrast agents • BRCA 1 or 2 mutation • Pregnant or lactating females; subjects in post-partum • Severe hypertension (systolic blood pressure >100 under treatment or uncontrolled hypertension with systolic pressure >160 and/or diastolic pressure >90)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the diagnostic efficacy of CEM with Iomeprole 400 mg I/ml (Iomeron®, Bracco) at a dose of 1 mL/Kg in patients with BIRADS 4 or 5 breast lesions.;Secondary Objective: To evaluate the quality of CEM images obtained with reduced volumes of a high-concentration contrast agent.;Primary end point(s): Main Parameters evaluations • Dose of contrast administered (mL) • Contrast flow rate (mL/s) • Creatinine • BUN • VFG • Serum Albumin • Na • K • eGFR

Secondary Outcome Measures