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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
02.01.2025

Trial locations

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.

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.

Trial ID:
2024-518549-27-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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