AuthorisedTherapeutic exploratory (Phase II)Interventional

DETECTION RATE AND CLASSIFICATION OF BREAST LESIONS WITH DIGITAL MAMMOGRAPHY WITH CONTRAST MEDIUM (CEDM) ALONE AND IN COMBINATION WITH TOMOSYNTHESIS COMPARED TO MR IMAGING WITH GADOLINIUM IN DYNAMICS (DCE-MRI) - CEDM-MRI

This research is looking at better ways to find and understand changes in the breast. We're directly comparing two advanced imaging techniques: a special type of mammogram that uses a contrast dye (CEDM), sometimes combined with a 3D mammogram (DBT), against a highly detailed MRI scan that also uses a contrast dye. The main goal is to see if these new mammogram methods are as good as, or even better than, the MRI scan at spotting and accurately describing breast problems. Researchers will also be studying the detailed images from all these methods to see if specific patterns in the pictures can help doctors understand more about breast lumps, including if they are harmless or need treatment, and even what type they are. This could help doctors make more informed decisions about patient care.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Enrolment target

400

Start

08 Jan 2025

breast pathology

What is this study about?

This study is designed to help us understand the best ways to detect and classify breast changes. Doctors currently use various imaging tests to look for problems in the breast, and this research aims to see how well some newer, advanced techniques compare to our existing methods.

Specifically, the study is comparing a special type of mammogram called 'Contrast-Enhanced Digital Mammography' (CEDM), which involves injecting a dye to make areas of concern stand out more clearly. Sometimes, this is combined with 'Tomosynthesis' (DBT), which is like a 3D mammogram, giving doctors a more detailed view. These are being compared against 'Contrast-Enhanced MRI' (CE-MRI), which is a very detailed scan that also uses a dye to highlight areas of interest. The main goal is to see if CEDM, by itself or with DBT, is as good as, or similar to, CE-MRI in finding breast problems and accurately describing what they are.

Beyond just finding abnormalities, the study also wants to see if we can get even more information from these images. Researchers will be carefully examining the pictures from all these different scans (CEDM, DBT, and MRI) to find unique patterns and textures. They hope these detailed patterns can help doctors tell the difference between harmless lumps and those that need treatment, and even understand more about the specific kind of breast change, which could guide treatment decisions. This research is important because it could lead to better and more precise ways of diagnosing breast conditions, ultimately helping patients get the most appropriate care.

Key takeaways

This study compares advanced breast imaging techniques.
It aims to see which scanning method is best for detecting and classifying breast conditions.
It involves special mammograms (CEDM, DBT) and MRI scans, all using a contrast dye.
The research hopes to find detailed patterns in images to understand breast lumps better.
Participation is for women aged 18 and over.
The study could lead to more accurate breast diagnoses in the future.

Who may be eligible?

This study is looking for women who are 18 years old or older. If you fit this age group, you might be able to take part.

However, there will be other specific health checks to make sure the study is right for you and that you can safely undergo the various scans and contrast dye injections. These checks will be explained in detail by the study team.

Participation is only open to women because the study is focused on breast conditions typical for females.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you 18 years old or older?
Are you able to have MRI scans?
Are you able to have contrast dyes injected for scans?
Do you have a breast condition or concern that would make you suitable for imaging?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be undergoing treatment for a disease, but rather exploring new diagnostic methods. You will receive several imaging tests, including different types of mammograms (some with contrast dye injected into your arm) and a detailed MRI scan (also with contrast dye). You will need to attend appointments for these scans. The specific number of visits and the total time involved will be explained by the study team, but generally, each scan appointment will take some time, including preparation. You will not be given any study medication to take at home; any interventions are related to the dyes used for imaging. After the scans, there might be follow-up to check on your health. The duration of your participation will depend on the study protocol, which the researchers will discuss with you.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to our understanding of better ways to diagnose breast conditions, which could help future patients. You might also receive very detailed imaging of your breasts. Potential risks include discomfort or allergic reactions from the contrast dyes used for the CEDM and MRI scans, and exposure to a small amount of radiation from the mammogram and tomosynthesis scans. You will be fully informed about these risks before deciding to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is the main goal of this study?

To compare different advanced breast imaging methods, like special mammograms and MRI, to see which is best at finding and describing breast changes.

What kind of scans will I have?

You'll have special mammograms (CEDM, sometimes with 3D DBT) and an MRI scan, all of which use a contrast dye.

What is 'contrast dye'?

It's a special liquid injected into your arm that helps doctors see certain areas more clearly on the scans.

Is this study offering a new treatment?

No, this study is about improving how we diagnose breast conditions, not about testing new treatments.

Who can take part?

Women who are 18 years old or older can be considered, but there will be further health checks to confirm eligibility.