Klinikum der Universitaet Muenchen AöR
Munich, Germany
Not yet recruiting
Safety and imaging quality study of perflutren contrast agent (HarMono-T) during kidney ultrasound in healthy volunteers
Verified siteInvestigational
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
9 criteria
- 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 trial?
13 criteria
- 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
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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.
What is already known about the treatment
HarMono-T - An investigational ultrasound contrast agent administered through intravenous injection, specifically designed for diagnostic imaging of kidney lesions. The medication consists of specialized microbubbles that enhance the visibility of kidney tissue during ultrasound examinations, helping physicians to better assess and characterize indeterminate kidney lesions. Currently undergoing Phase I/II clinical trials to evaluate its safety, tolerability, and imaging effectiveness in healthy subjects, this diagnostic agent represents a new approach in medical imaging technology. The agent belongs to the pharmacological class of diagnostic contrast media, working by creating enhanced acoustic reflection during ultrasound procedures.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514924-17-00Protocol codeCTSP-001Estimated enrolment20 patientsSponsorSolstice Pharmaceuticals B.V.
sourced from the EU Clinical Trials Register and site verification
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