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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2024-07-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bracco Suisse SA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Efficacy

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 objectives 1

1. To evaluate the quality of CEM images obtained with reduced volumes of a high-concentration contrast agent.

Conditions and MedDRA coding

Breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Main Parameters evaluations • Dose of contrast administered (mL) • Contrast flow rate (mL/s) • Creatinine • BUN • VFG • Serum Albumin • Na • K • eGFR

Secondary endpoints 1

1. • Pre-CEM mammography and breast ultrasound • Follow-up mammography and breast ultrasound, 6 and 12 months after CEM

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Sponsor organisation

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Address

Viale Del Policlinico 155

City

Rome

Postcode

00161

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Contact name

Federica Pediconi

Public contact point

Organisation

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Contact name

Federica Pediconi

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications