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Study to evaluate gadopiclenol-enhanced magnetic resonance imaging for diagnosis in patients with breast cancer

Registered drugNo placebo
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What is this trial about?

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

This study focuses on patients with breast cancer and aims to investigate how well a contrast agent called gadopiclenol (Elucirem) works during magnetic resonance imaging examinations. Magnetic resonance imaging (MRI) is a medical scanning technique that creates detailed pictures of the inside of the body.

The study involves giving patients an injection of gadopiclenol before their scheduled MRI scan. This contrast agent helps make certain areas of the body more visible during the scan. The examination will take place before planned breast cancer surgery. The dose of gadopiclenol used in the study is 0.5 millimoles per milliliter, given as a single injection.

During the study, doctors will compare the detailed images from the MRI scan with the results from examining the breast tissue after surgery. They will look at various features of the cancer seen on the MRI images, such as size and appearance, and compare these with the actual characteristics of the tumor found during laboratory examination of the surgically removed tissue. This will help determine how accurate the contrast-enhanced MRI is in showing the details of breast cancer.

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

    Initial magnetic resonance imaging (MRI) examination

    You will undergo a multiparametric magnetic resonance imaging examination of the breast area

    During the examination, you will receive an injection of Elucirem (gadopiclenol) at a concentration of 0.5 mmol/mL

    The imaging will help evaluate the characteristics of breast tissue and any abnormal areas

  2. Step 2

    Image analysis

    The MRI images will be analyzed to assess:

    The size and type of any detected lesions

    The shape and appearance of breast tissue

    How the contrast material enhances different areas

    Background breast tissue enhancement patterns

  3. Step 3

    Surgical procedure

    You will undergo the planned surgical removal of breast tissue

    The removed tissue will be examined by pathologists to determine:

    The exact size of the tumor

    The grade of the cancer

    The molecular characteristics of the cancer

  4. Step 4

    Safety monitoring

    Throughout the study period, any unexpected effects or reactions will be documented

    Your health status will be monitored after receiving the contrast agent

Who can join the trial?

7 criteria

  • Must be a female patient aged 18 or older
  • Must have either:
    • A confirmed breast cancer diagnosis through core needle biopsy (a procedure where a small sample of breast tissue is removed and examined), or
    • Highly suspicious findings on previous imaging tests (BI-RADS 4C-5, which means there is a high probability of cancer based on breast imaging)
    • Must be scheduled for preoperative multiparametric magnetic resonance imaging (a detailed MRI scan of the breast that provides multiple types of images) as part of regular diagnostic process
    • Must be planned for surgical removal of the tumor
    • Must agree to participate by signing an informed consent form before joining the study
    • Must be willing to have tissue samples examined after surgery (histopathological analysis)

Who cannot join the trial?

10 criteria

  • Patients who have contraindications to MRI examination (such as having metal implants, pacemakers, or severe claustrophobia)
  • Patients who are allergic to gadolinium-based contrast agents (substances used during MRI to make images clearer)
  • Male patients (this study is designed for female participants only)
  • Patients younger than 18 years old
  • Pregnant or breastfeeding women
  • Patients with severely reduced kidney function (as contrast agents may be harmful)
  • Patients who had previous breast surgery in the area to be examined
  • Patients who cannot lie still for the duration of the MRI examination
  • Patients who have received chemotherapy or radiation therapy for breast cancer within the past 6 months
  • Patients who are unable to provide informed consent
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Investigated drugs

Gadopiclenol is a contrast agent used during magnetic resonance imaging (MRI) procedures. It helps make certain tissues and blood vessels more visible during the scan, particularly in breast cancer imaging. When injected into the body, it enhances the quality of MRI images, allowing doctors to better see and evaluate breast tissue abnormalities and potential cancer areas. This contrast agent helps distinguish between normal and abnormal breast tissue, which is crucial for accurate diagnosis and surgical planning.

What is already known about the treatment

Gadopiclenol - A contrast agent administered intravenously for magnetic resonance imaging (MRI) examinations, particularly in breast cancer diagnostics. This substance belongs to the gadolinium-based contrast agents class and is used to enhance the visibility of tissues and blood vessels during MRI scans, helping to identify and characterize breast tumors more accurately. Gadopiclenol works by altering the magnetic properties of nearby water molecules, creating better contrast in MRI images, which allows radiologists to distinguish between normal and abnormal tissue structures. The medication represents a newer generation of MRI contrast agents designed to provide high-quality diagnostic images while maintaining a favorable safety profile.

Investigated diseases

Breast cancer - A disease that occurs when cells in the breast tissue begin to grow abnormally and uncontrollably. The cancer typically starts in either the lobules (milk-producing glands) or the ducts (passages that carry milk to the nipple). As the disease progresses, cancer cells can form a mass or tumor within the breast tissue. Breast cancer can develop in both women and men, though it is much more common in women. The disease may spread from its original location to nearby lymph nodes and potentially to other parts of the body. The progression and behavior of breast cancer can vary significantly between different types and subtypes of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521810-24-00Protocol codeGAPI-PRIMEEstimated enrolment30 patientsSponsorFundacion Ribera Salud

sourced from the EU Clinical Trials Register and site verification

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