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Pilot study to explore the diagnostic value of gadopiclenol in pathological and radiological insights with multiparametric MRI enhancement in breast cancer.
EU CTIS ID: 2025-521810-24-00
What this study is testing
To investigate the correlation between gadopiclenol-enhanced multiparametric magnetic resonance imaging findings with histopathological results from breast cancer surgery.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female patients ≥ 18 years old with confirmed diagnosis of breast cancer by core needle biopsy or highly suspicious based on previous imaging examination (BI-RADS 4C-5).
- Patients who give written informed consent prior to their inclusion in the study.
- The patients must be scheduled for preoperative multiparametric magnetic resonance imaging as part of their standard diagnostic workup and for surgical resection of the tumor, with available histopathological data post-surgery.
You likely can't join if
- Patients with prior breast cancer or breast surgery, including excisional biopsy.
- Patients that have received neoadjuvant chemotherapy before undergoing magnetic resonance imaging.
- Patients who are pregnant or breastfeeding, as well as those with contraindications to magnetic resonance imaging, such as metallic implants or pacemakers.
- Patients with severe renal impairment, defined by an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m² due to the risks associated with gadolinium-based contrast agents.
- Patients with known allergic reactions to gadolinium-containing contrast agents, including gadopiclenol.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.