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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Pilot study to explore the diagnostic value of gadopiclenol in pathological and radiological insights with multiparametric MRI enhancement in breast cancer.

This research is a pilot study, which means it's a small-scale, early look into how a specific type of MRI scan works for breast cancer. The scan uses a special dye called Elucirem. We want to see how well the details seen on the MRI — like the size, shape, and how the cancer lights up with the dye — match up with what doctors find when they look at breast tissue under a microscope. This comparison helps us understand if this advanced MRI can give clearer and more accurate pictures of breast cancer. The goal is to improve how we diagnose and understand breast cancer, potentially leading to better treatment plans in the future.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Fundacion Ribera Salud
Enrolment target
30
Start
05 Sep 2025

What is this study about?

This study is like a detective story, trying to get a clearer picture of breast cancer. Doctors use a special type of MRI scan, which is a powerful way to look inside the body without surgery. For this scan, they use a special dye, sometimes called a 'contrast agent,' named Elucirem, which helps make certain areas, like tumours, show up more clearly on the scan.

The main aim is to see how accurate these special MRI scans are. We're comparing what the MRI scan shows – things like the size of the cancer, its shape, and how it responds to the dye – with what doctors find when they examine breast tissue very closely under a microscope. This examination, called 'histopathology,' gives very detailed information about the cancer, such as its exact type, how aggressive it is, and if it has spread to nearby lymph nodes.

By carefully comparing the MRI findings with the microscopic details, we hope to learn if this advanced MRI technique can give a more precise and helpful understanding of breast cancer. This information could make a real difference, helping doctors diagnose the cancer more accurately and plan the best treatment for each patient.

Key takeaways

  • Study explores a special MRI scan for breast cancer using Elucirem dye.
  • Compares MRI images with detailed tissue analysis to improve diagnosis.
  • Aims to understand breast cancer better for future patient care.
  • Participants will undergo MRI scans and provide information from tissue samples.
  • Only for adult women (18 years and older) diagnosed with breast cancer.

Who may be eligible?

This study is for adult women, meaning you need to be 18 years old or older to take part. There isn't an upper age limit mentioned, so older adults could also be considered.

Generally, participants would need to have been diagnosed with breast cancer. The key is that researchers are looking for specific details about the cancer, both from the MRI scan and from tissue samples, to compare them. More specific details about the type or stage of breast cancer you have might be discussed with the study team.

As this is an early-stage study, the number of people they can include might be limited, and they'll be looking for participants who fit very specific health requirements to make sure the study results are clear and reliable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you a woman?
  3. Have you been diagnosed with breast cancer?
  4. Are you generally in good health otherwise for a study like this?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll mainly be having a special type of MRI scan. This scan uses a specific dye called Elucirem, which will be given to you as an injection, usually into a vein in your arm, just before the scan. The study team will need to use information from your MRI scan (things like the size and shape of any growths) and also details from your breast tissue samples that have already been taken for diagnosis (such as the cancer's type and how it behaves).

There might be additional visits to the clinic for assessments before, during, or after the scan, where doctors will check on your health and collect information about any effects you might experience from the dye. They will also keep track of any side effects you might have. The total duration of your active involvement in the study would depend on the number of scans and follow-up checks required, but specific details would be explained fully by the study team.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by helping doctors learn more about breast cancer and how best to detect it, which could lead to better diagnoses and treatments for future patients. While unlikely, there's always a small risk associated with receiving an injected dye for an MRI scan, such as an allergic reaction or discomfort at the injection site. The study team will closely monitor you for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What is Elucirem?

Elucirem is a special dye, sometimes called a 'contrast agent,' that helps show clearer pictures during an MRI scan. It's injected into your body.

What is multiparametric MRI?

It's an advanced type of MRI scan that gathers several different kinds of information about an area of the body, helping doctors get a very detailed view.

Why compare MRI with tissue samples?

By comparing, doctors want to see if what the MRI shows accurately matches what they find when looking at actual breast tissue under a microscope. This improves understanding and diagnosis.

Will this study change my cancer treatment?

This study is focused on learning more about diagnosis. Any treatment decisions will still be made by your doctors based on your overall health and the standard care guidelines.

Is this a new medicine being tested?

No, this study is about checking how useful an existing diagnostic dye (Elucirem) is with MRI scans, not testing a new cancer treatment itself.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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