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Study on Detecting and Classifying Breast Disease Using Iodixanol in Digital Mammography and Tomosynthesis Compared to MRI in Patients with Breast Pathology

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial focuses on studying the detection and classification of breast lesions using different imaging techniques. The study involves comparing Digital Mammography with Contrast Medium (CEDM), both alone and combined with Tomosynthesis, to Magnetic Resonance Imaging (MRI) that uses a substance called Gadolinium. The main goal is to evaluate how well these methods can identify and accurately diagnose breast conditions, including the presence of multiple tumors in one or both breasts.

The trial uses a special contrast agent called Visipaque, which contains the active substance iodixanol. This agent is injected into the body to help highlight areas of interest during imaging. The study aims to determine if CEDM, with or without tomosynthesis, is as effective as MRI in detecting and diagnosing breast lesions. Additionally, the study will assess the ability of these imaging techniques to classify breast lesions as benign or malignant and to identify specific tumor characteristics, such as luminal A, luminal B, HER2-positive, and triple-negative types.

Participants in the study will undergo imaging tests using the different methods mentioned. The study will compare the results to see which method provides the most accurate information about breast lesions. This research is important for improving the diagnosis and treatment planning for individuals with breast conditions, potentially leading to better outcomes and more personalized care.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, suspected or confirmed breast pathology, and recent serum creatinine measurement to ensure kidney function is adequate.
Eligibility criteria include being over 18 years old, having suspected or confirmed breast pathology, and having an estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m².
Step 2
Informed consent
Full information about the study is provided. The patient is required to sign an informed consent form to participate in the study.
Step 3
Contrast-enhanced digital mammography (CEDM)
The patient undergoes a contrast-enhanced digital mammography (CEDM) procedure. This involves the use of a contrast medium to improve the visibility of breast tissues.
The contrast medium used is iodixanol, administered intravenously as a solution for injection under the product name VISIPAQUE 320 mg I/ml.
Step 4
Tomosynthesis
In combination with CEDM, a tomosynthesis procedure is performed. This is a type of 3D mammography that provides a clearer view of breast tissues.
Step 5
Magnetic resonance imaging (MRI)
The patient undergoes a magnetic resonance imaging (MRI) scan. This includes both contrast-enhanced MRI (CE-MRI) and dynamic contrast-enhanced MRI (DCE-MRI) to compare with the results from CEDM and tomosynthesis.
Step 6
Evaluation and follow-up
The detection rate and diagnostic accuracy of the imaging techniques are evaluated. The study aims to determine the equivalence or comparability of CEDM alone and in combination with tomosynthesis compared to MRI.
Secondary evaluations include assessing the diagnostic accuracy of a radiomic signature from the imaging modalities in classifying breast lesions.

Who can join the trial?

5 criteria

Must be over 18 years old.
Must have a suspected **breast condition** or be in the process of planning surgery for a breast condition that has already been confirmed by standard imaging tests like **Ultrasound** or **traditional 2D Mammography**, or by a **cytological/histopathological examination**. These are tests that look at cells or tissues under a microscope.
Must receive full information about the study and sign a document called an **informed consent** to agree to participate in the study.
Can have the required exams done at any time during their **menstrual cycle**.
Must have a kidney function test result, called **estimated glomerular filtration rate (eGFR)**, greater than 60 mL/min/1.73 m². This is a measure of how well the kidneys are working, and it should be done within two weeks before joining the study.

Who cannot join the trial?

4 criteria

Individuals who do not have a condition related to breast pathology cannot participate. Breast pathology refers to any disease or disorder affecting the breast.
Only females are eligible to participate, so males are excluded from the study.
Participants must fall within specific age ranges, so those outside these age groups cannot join the study.
Individuals who are considered part of a vulnerable population are excluded. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk of harm.

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IRCCS Istituto Nazionale Tumori Fondazione Pascale
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Naples, Italy

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Investigated drugs

Digital Mammography with Contrast Medium (CEDM)
is a type of breast imaging that uses a contrast agent to enhance the visibility of breast tissues. This method helps in detecting and classifying breast lesions by providing clearer images, which can be crucial for identifying abnormalities.
Tomosynthesis
is an advanced form of mammography that creates a three-dimensional image of the breast. When combined with CEDM, it can improve the detection and diagnostic accuracy of breast lesions by providing more detailed images from different angles.
Magnetic Resonance Imaging (MRI) with Gadolinium
is a technique that uses magnetic fields and a contrast agent called gadolinium to produce detailed images of the breast. This method is used to evaluate the presence and extent of breast pathology, offering a comprehensive view of the breast tissue.

What is already known about the treatment

Gadolinium – Gadolinium is administered intravenously as a contrast agent during MRI scans. It is currently widely used in medical imaging to enhance the clarity of MRI images, particularly in detecting and diagnosing various conditions, including breast pathology. The main therapeutic indication for gadolinium is to improve the visibility of internal structures in MRI scans, aiding in the accurate diagnosis of diseases. At the molecular level, gadolinium works by altering the magnetic properties of nearby water molecules, which enhances the contrast of the images produced. It is classified as a contrast agent in pharmacology.

Investigated diseases

Breast Pathology – Breast pathology refers to a range of conditions affecting the breast tissue, including benign and malignant changes. It encompasses various abnormalities such as lumps, cysts, and tumors, which can be either non-cancerous or cancerous. The progression of breast pathology can vary significantly depending on the specific condition. Some conditions may remain stable or resolve on their own, while others, like breast cancer, may grow and spread to other parts of the body. Breast pathology can also involve multifocality, where multiple areas within the same breast are affected, multicentricity, where different areas in the breast are involved, and bilaterality, where both breasts are affected. Understanding the nature and progression of these conditions is crucial for determining the appropriate management and monitoring strategies.