Kuopio University Hospital
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Kuopio, Finland
Not yet recruiting
Study on Using Perflubutane in Ultrasound Imaging for Patients Needing Lymphatic Imaging
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a new technique for imaging the lymphatic system, which is a part of the body's immune system. The study involves using a method called contrast enhanced ultrasound to help visualize the lymphatic vessels. This technique is being tested to see if it can effectively show the superficial lymphatic vessels, which are the small channels that help transport lymph fluid throughout the body.
The treatment being used in this study is a special type of ultrasound contrast agent called Sonazoid, which contains the active substance perflubutane. This contrast agent is injected into the skin to help improve the visibility of the lymphatic vessels during the ultrasound imaging process. The study aims to determine how well this contrast agent works in making the lymphatic vessels more visible.
The purpose of the study is to evaluate the feasibility of using contrast enhanced ultrasound for lymphatic imaging. Participants in the study will receive an injection of the contrast agent, and then ultrasound imaging will be performed to see how well the lymphatic vessels can be visualized. The study is designed to gather information on the effectiveness of this imaging technique, which could potentially lead to better ways of diagnosing and understanding conditions related to the lymphatic system.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Must be a volunteer.
- Must be a breast cancer patient.
- Must be between the ages of 18 and 65.
- Both females and males can participate.
- Participants should not belong to a vulnerable population, which means they should not be in a group that needs special protection or care.
Who cannot join the trial?
4 criteria
- Patients who are not within the specified age range cannot participate.
- Patients who are part of a vulnerable population are not eligible.
- Patients with medical conditions that interfere with the study's objectives are excluded.
- Patients who cannot undergo a contrast enhanced ultrasound (a special imaging test that uses sound waves and a contrast agent to create pictures of the inside of the body) are not eligible.
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Investigated drugs
The clinical trial focuses on a technique rather than specific medications. It involves the use of **contrast enhanced ultrasound**. This is a special type of ultrasound that uses a contrast agent to help doctors see the lymphatic vessels more clearly. The contrast agent is a liquid that is injected into the body, and it helps to highlight the lymphatic vessels on the ultrasound images. This technique is being studied to see if it can provide better images of the lymphatic system, which could help in diagnosing and treating various conditions related to the lymphatic vessels.
What is already known about the treatment
Contrast Agent for Ultrasound – This medication is administered through injection and is used in a procedure called contrast-enhanced ultrasound, which helps in imaging the lymphatic system. Currently, it is being studied for its effectiveness in visualizing superficial lymphatic vessels, a technique that is still under research. The main therapeutic indication is for lymphatic imaging, where it helps doctors see the lymphatic vessels more clearly. At the molecular level, the contrast agent works by enhancing the reflection of ultrasound waves, making the lymphatic vessels more visible on the ultrasound images. It is classified pharmacologically as a diagnostic imaging agent.
Investigated diseases
Lymphatic Imaging – Lymphatic imaging is not a disease but a process used to visualize the lymphatic system, which includes lymph nodes and vessels. The lymphatic system is part of the immune system and helps in the removal of waste and toxins from the body. This imaging is crucial for identifying abnormalities in the lymphatic system, such as blockages or malformations. It can help in understanding conditions like lymphedema, where there is swelling due to lymph fluid buildup. The imaging process often involves the use of contrast agents to enhance the visibility of lymphatic structures. This technique aids in the detailed study of lymphatic vessel function and structure.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-519077-19-01Estimated enrolment100 patientsSponsorKuopio University Hospital
sourced from the EU Clinical Trials Register and site verification
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