Safety and imaging quality study of perflutren contrast agent (HarMono-T) during kidney ultrasound in healthy volunteers

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What is this study about?

This study evaluates a new contrast agent called HarMono-T used during ultrasound examinations of the kidney. The contrast agent contains perflutren, which helps create better images during kidney imaging procedures. The purpose is to test how safe this contrast agent is and how well it works in creating clear images of the kidneys.

During the study, healthy individuals will receive a single dose of HarMono-T through an intravenous injection. Four different dose levels will be tested. The contrast agent consists of tiny bubbles that improve the visibility of kidney structures during ultrasound imaging. After receiving the injection, participants will undergo kidney ultrasound examinations to assess how well the contrast agent works.

The study will monitor participants’ health through various medical checks, including blood tests and heart monitoring. A final ultrasound examination will be performed 30 minutes after receiving the contrast agent to confirm that it has completely cleared from the body. Participants will be followed for approximately one week after receiving the injection to check for any potential side effects.

1 Initial examination and dose administration

You will receive a single intravenous (IV) dose of HarMono-T contrast agent.

The medical team will perform a physical examination, check your vital signs, and conduct a 12-lead ECG (heart activity recording).

Blood samples will be collected to assess your blood count, kidney, and liver functions.

2 Kidney ultrasound imaging

An ultrasound examination of your kidneys will be performed using the contrast agent.

The imaging process will measure several parameters including:

– Time to reach maximum contrast enhancement

– Peak contrast enhancement levels

– Rate of contrast agent appearance and disappearance in kidney tissue

3 Post-dose monitoring

After 30 minutes, another ultrasound will be performed to confirm that the contrast agent has cleared from your system.

Your vital signs and heart activity will be monitored throughout this period.

4 Follow-up period

You will be monitored for any side effects for 7 days (plus or minus 2 days) after receiving the contrast agent.

Additional blood tests, vital sign measurements, and ECG recordings will be performed during this period.

Any unusual symptoms or reactions will be documented and assessed.

Who Can Join the Study?

  • Must be able to provide written informed consent (formal agreement to participate) and follow all study requirements
  • Must be at least 18 years old
  • Must be in good overall health, which will be determined by:
    • Medical history review
    • Physical examination
    • Laboratory test results
    • Vital signs measurements (such as blood pressure and heart rate)
    • 12-lead ECG (a test that records the electrical activity of the heart)
  • Can be either male or female
  • Must not be part of a vulnerable population (such as prisoners or persons unable to give consent)

Who Cannot Join the Study?

  • Age below 18 or above 55 years
  • Current pregnancy or breastfeeding
  • History of allergic reactions to medical contrast agents (substances used to improve medical imaging)
  • Significant heart or lung conditions
  • Any active or chronic medical conditions that could affect the study results
  • Participation in another clinical trial within the past 30 days
  • Current use of medications that could interact with the study drug (HarMono-T microbubbles)
  • Abnormal kidney or liver function test results
  • History of blood clotting disorders
  • Recent surgery (within the past 3 months)
  • Current drug or alcohol abuse
  • Any condition that could interfere with the ability to follow study procedures
  • History of serious medical conditions that could affect safety during the study

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Knlhmxag ddb Uyqurkmbawsm Mllzwzzo Axe Munich Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
01.07.2025

Trial locations

Investigated drugs:

HarMono-T is a contrast agent used during ultrasound imaging procedures. It consists of tiny gas-filled microbubbles that help improve the visibility of organs and blood vessels during ultrasound examinations. When injected into a vein, these microbubbles enhance the ultrasound images of the kidneys, making it easier for doctors to see the organ’s structure and blood flow patterns in detail.

Indeterminate Kidney Lesions – A condition where abnormal tissue growths or masses are found in the kidneys, but their exact nature cannot be determined through initial imaging. These lesions appear as unclear or ambiguous areas on standard imaging tests. They can vary in size and characteristics, making them difficult to classify definitively without additional diagnostic procedures. Such lesions may represent either benign cysts, solid masses, or other kidney abnormalities. The condition requires careful monitoring and additional imaging studies to better understand the nature of the lesions.

Note: In this clinical trial context, the focus is on using ultrasound contrast agents for better visualization and characterization of these kidney lesions.

Trial ID:
2024-514924-17-00
Protocol code:
CTSP-001
Trial Phase:
Human Pharmacology (Phase I) – Other

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