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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Universitario Del Vinalopo	Elche	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	15.09.2025

Trial locations

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.

Investigated diseases:

Breast cancer female

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 ID:

2025-521810-24-00

Protocol code:

GAPI-PRIME

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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