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Study on Low-Dose Gadolinium for Breast Cancer MRI in Patients Using Gadoteric Acid

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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 Breast Cancer and involves the use of a special imaging technique called MRI (Magnetic Resonance Imaging). The study will use a contrast agent known as gadoteric acid, which is marketed under the name DOTAREM. This contrast agent is given through an injection to help create clearer images of the breast tissue during the MRI scan.

The purpose of the study is to determine if using a lower dose of gadoteric acid with the help of advanced computer technology can provide images that are just as clear and useful for diagnosis as the standard higher dose. This approach aims to maintain the quality of the images while potentially reducing the amount of contrast agent needed.

Participants in the study will undergo a contrast-enhanced breast MRI using the reduced dose of the contrast agent. The quality of the images will be evaluated both qualitatively, which means looking at the images to see how clear they are, and quantitatively, which involves measuring specific aspects of the images. The study will also assess how well the images can help in diagnosing breast cancer. The trial is expected to continue until 2026.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting the criteria: being an adult woman over 18 years old, scheduled for a contrast-enhanced breast MRI.
No specific exclusion criteria are mentioned.
Step 2
Preparation for MRI
Before the MRI, preparation involves understanding the procedure and the use of a contrast agent called gadoteric acid.
The contrast agent is administered through an intravenous injection.
Step 3
MRI procedure
The MRI uses a reduced dose of gadoteric acid to enhance the images of the breast.
The objective is to determine if the images are of equivalent quality to those obtained with the standard dose.
Step 4
Image evaluation
The primary focus is on the qualitative and quantitative evaluation of the image quality.
Secondary evaluation involves assessing the diagnostic performance of the images.
Step 5
Completion of study participation
Participation concludes after the MRI and image evaluations are completed.
The study aims to finish by August 28, 2026.

Who can join the trial?

2 criteria

Must be an adult woman over 18 years old.
Must be scheduled to have a contrast-enhanced breast MRI. This is a special type of imaging test that uses a dye to help see the breast tissue more clearly.

Who cannot join the trial?

8 criteria

Participants must not have any other serious health conditions that could interfere with the study.
Participants should not be pregnant or breastfeeding.
Participants must not have any allergies to **gadolinium**, which is a substance used in MRI scans to help create clearer images.
Participants should not have any metal implants or devices in their body that could be affected by the MRI machine.
Participants must not have any kidney problems, as these could be affected by the **gadolinium** used in the MRI.
Participants should not have had any recent surgeries or procedures that could interfere with the study results.
Participants must not be part of any other clinical trial at the same time.
Participants should not have any mental health conditions that could make it difficult to follow the study instructions.

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Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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Investigated drugs

Gadolinium is a contrast agent used in MRI scans to help create clearer images of the body's internal structures. In this trial, a reduced dose of gadolinium is being tested to see if it can provide the same quality of images as the standard dose when enhanced with artificial intelligence. This could potentially reduce the amount of gadolinium needed, which may be beneficial for patients.

Gadoteric Acid

What is already known about the treatment

Gadolinium – Gadolinium is administered intravenously as a contrast agent during MRI scans. It is currently used in medical imaging to enhance the clarity of MRI images, particularly in detecting abnormalities such as tumors. In the context of breast cancer, gadolinium helps in obtaining detailed images of breast tissue to aid in diagnosis. At the molecular level, gadolinium works by altering the magnetic properties of nearby water molecules, which enhances the contrast of the images. 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 or other parts of the body. The growth of these cells can form a lump or mass, which may be detected through physical examination or imaging. Changes in the size, shape, or appearance of the breast or nipple may occur. Early stages may not cause noticeable symptoms, but as it advances, more significant changes can be observed.