Study on Using Perflubutane in Ultrasound Imaging for Patients Needing Lymphatic Imaging

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What is this study about?

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.

1 joining the study

Upon joining the study, participants are required to confirm their eligibility. Eligible participants include volunteers and breast cancer patients.

2 initial consultation

Participants attend an initial consultation where the study procedure is explained. Any questions regarding the study are addressed during this session.

3 preparation for procedure

Participants are prepared for the procedure. This involves ensuring that the participant is comfortable and ready for the injection.

4 administration of contrast agent

The contrast agent, Sonazoid, is administered through an intradermal injection. This means the injection is given just under the skin. The agent used is a dispersion for injection containing perflubutane.

5 ultrasound imaging

After the injection, an ultrasound is performed to visualize the superficial lymphatic vessels. This is the primary objective of the study.

6 post-procedure observation

Participants are observed for a short period after the procedure to ensure there are no immediate side effects from the injection.

7 follow-up

Participants may be required to attend follow-up appointments to monitor any delayed reactions and to discuss the results of the imaging.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kuopio University Hospital Kuopio Finland

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not yet recruiting
01.04.2020

Trial locations

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.

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 ID:
2024-519077-19-01
Trial Phase:
Therapeutic use (Phase IV)

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