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Study on the Use of Iomeprol in Contrast Enhanced Mammography for Identifying Breast Cancer in Patients with BIRADS 4 or 5 Lesions

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a diagnostic technique called *Contrast Enhanced Mammography* (CEM) in identifying *breast cancer*. The study uses a contrast agent known as *Iomeprol* (also referred to as Iomeron, Bracco) at a concentration of 400 mgI/ml. This contrast agent is administered through an injection to help highlight areas of concern in the breast tissue during mammography, which is an X-ray technique used to examine the breast.

The purpose of the study is to evaluate how well CEM with *Iomeprol* can identify breast lesions that are classified as BIRADS 4 or 5. BIRADS is a system used by doctors to categorize the level of suspicion for cancer in breast imaging findings, with 4 and 5 indicating a higher likelihood of cancer. Participants in the study will receive a dose of the contrast agent based on their body weight, specifically 1 mL per kilogram. The study will involve initial mammography and ultrasound examinations, followed by additional imaging at 6 and 12 months after the CEM procedure to monitor any changes.

Throughout the study, various health parameters will be monitored, including kidney function tests such as creatinine and eGFR, as well as other blood components like serum albumin, sodium, and potassium. These tests help ensure the safety of the participants while assessing the effectiveness of the CEM technique in detecting breast cancer. The study aims to provide valuable insights into the potential benefits of using *Iomeprol* in enhancing mammography for better cancer detection.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be female, aged 35 or older, and have undergone a mammogram within the last five weeks. A breast lesion requiring further assessment with a biopsy must be present, classified as BIRADS 4 or 5, or there must be a suspicion of malignancy from an ultrasound that cannot be evaluated with a mammogram.

    Written informed consent is required, and participants must agree to follow the study protocol.

  2. Step 2

    Contrast enhanced mammography (CEM)

    Participants undergo a contrast enhanced mammography using Iomeprol 400 mgI/ml, also known as Iomeron. The contrast is administered at a dose of 1 mL per kilogram of body weight through an injection.

    The procedure aims to evaluate the diagnostic efficacy of CEM in identifying breast cancer in patients with BIRADS 4 or 5 lesions.

  3. Step 3

    Primary evaluations

    Key parameters are assessed, including the dose of contrast administered, the flow rate of the contrast, and various blood tests. These tests measure creatinine, blood urea nitrogen (BUN), glomerular filtration rate (GFR), serum albumin, sodium (Na), and potassium (K).

  4. Step 4

    Secondary evaluations

    Before the CEM, a mammogram and breast ultrasound are conducted. Follow-up mammograms and ultrasounds are scheduled for 6 and 12 months after the initial CEM to monitor any changes.

Who can join the trial?

6 criteria

  • Female patients who are **35 years of age or older**.
  • Patients who have had a **mammogram** (an X-ray of the breast) in the last **5 weeks** before joining the study.
  • Patients with a **breast lesion** (an area of abnormal tissue) that needs more testing with a **biopsy** (a small sample of tissue taken for testing).
  • Patients with a **BIRADS 4 or 5 breast lesion** seen on a mammogram. BIRADS is a system used to describe the findings on a mammogram, with 4 and 5 indicating a suspicion of cancer.
  • Patients with a **suspicious lesion** seen on an **ultrasound** (a test that uses sound waves to look at the inside of the body) that cannot be evaluated with a mammogram.
  • Patients who agree to participate by providing their **written informed consent** and are willing to follow the study's rules and requirements.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have breast lesions classified as BIRADS 4 or 5 cannot participate. BIRADS is a system used to categorize breast imaging findings, with 4 and 5 indicating suspicious or highly suspicious findings.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who belong to a vulnerable population, which means groups that might need special protection, cannot participate.
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Investigated drugs

Iomeprol: This is a contrast agent used in medical imaging. In this trial, it is used in contrast-enhanced mammography to help identify breast cancer. The contrast agent helps to improve the visibility of breast tissues, making it easier to detect any abnormalities or lesions that may indicate the presence of cancer.

What is already known about the treatment

Iomeprol – Iomeprol is administered as an intravenous injection, typically used in contrast-enhanced mammography to help identify breast cancer. It is currently being studied in clinical trials to assess its effectiveness in diagnosing breast lesions classified as BIRADS 4 or 5. The main therapeutic indication for Iomeprol is to enhance imaging clarity, allowing for better visualization of potential cancerous tissues. At the molecular level, Iomeprol works by increasing the contrast of images in mammography, which helps in distinguishing between different types of tissues. It is classified as a contrast agent in pharmacology.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It often begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby tissues and lymph nodes. The growth of cancer cells can form a lump or mass in the breast, which may be detected through physical examination or imaging tests. Over time, if untreated, the cancer may metastasize to other parts of the body. The progression and symptoms can vary widely among individuals, with some experiencing changes in breast shape, skin texture, or nipple discharge.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513251-32-00Protocol codeI3-MaC StudyEstimated enrolment173 patientsSponsorAzienda Ospedaliero-Universitaria Policlinico Umberto I

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