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NCT Number: NCT06994260

Diagnostic Imaging of Vascular Malformations Using MSOT and ULM

This clinical study evaluates the efficacy and accuracy of Multispectral Optoacoustic Tomography (MSOT) and Ultrasound Localization Microscopy (ULM) for imaging and diagnosing vascular malformations (venous, arteriovenous, lymphatic). The study aims to enhance diagnostic precision and improve treatment planning through advanced non-invasive imaging techniques.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen, Department of Vascular Surgery

Erlangen, Bavaria, 91054, Germany

Location contact

Rabah F. Sankari

SUB_INVESTIGATOR

Ulrich Rother, PD Dr. med.

CONTACT

[email protected]

+4991318542028

About this study

This study aims to investigate whether Multispectral Optoacoustic Tomography (MSOT) and Ultrasound Localization Microscopy (ULM) can accurately differentiate between lymphatic, venous, and arteriovenous vascular malformations. MSOT can determine oxygen levels based on the expected low oxygen content in venous blood, high oxygen content in arterial blood, and the absence of oxygen in lymphatic fluid. Additionally, ULM, utilizing microbubbles, measures blood flow velocities, which may help identify and distinguish these malformations or their mixed forms.

To date, vascular malformations of blood and lymphatic vessels are commonly diagnosed using cross-sectional imaging techniques such as ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). MSOT introduces a novel, non-invasive diagnostic approach that enables the assessment of oxygenated hemoglobin concentrations and oxygen levels in blood and tissue. Previous studies (e.g., MSOT_IC, MSOT_PI) demonstrated the capability of MSOT to visualize muscle perfusion in patients with peripheral arterial disease. Moreover, it has successfully identified muscle structures and the clinical severity of Duchenne muscular dystrophy by detecting endogenous biomarkers like collagen and lipids.

The objective of this study is to utilize MSOT and ULM as supplementary diagnostic tools to conventional imaging methods to accurately identify and distinguish between venous, arteriovenous, and lymphatic malformations in patients. This approach has the potential to reduce exposure to ionizing radiation from CT scans and minimize the need for resource-intensive MRI procedures in the future.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed vascular malformations (arteriovenous, venous, or lymphatic).
  • ≥18 years old and able to give their consent

Exclusion criteria

  • No imaging for diagnostic confirmation has been performed or is planned.
  • Lack of written consent
  • <18 years old
  • Safety concerns of the study physician (a patient with physical, psychological, or psychiatric conditions that, in the opinion of the study physician, could compromise the patient's safety or the quality of the data, thereby making the patient an unsuitable candidate for the study).

Treatment and study plan

Multispectral Optoacoustic Tomography

Diagnostic Test

MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research.

In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

Ultrasound Localization Microscopy

Diagnostic Test

ULM is a cutting-edge imaging technique that significantly enhances the resolution of traditional ultrasound by tracking the movement of microbubble contrast agents within blood vessels. This approach enables the visualization of microvascular structures and blood flow dynamics at a super-resolution scale, beyond the diffraction limit of conventional ultrasound.

In this study, we aim to utilize ULM to differentiate between venous, arteriovenous and lymphatic malformations.

Primary outcomes

  1. Quantitative signal of total hemoglobin (HbT), oxygenated hemoglobin (HbO2), deoxygenated hemoglobin (Hb), and oxygen saturation (mSO2).

    Time frame: through study completion, an average of 1 year

    using MSOT

  2. Quantification of perfusion dynamics in the respective vessel.

    Time frame: through study completion, an average of 1 year

    using ULM

Study contacts

Contact information is provided by the study sponsor or research team.

Ulrich Rother, PD Dr. med.

CONTACT

[email protected]

+4991318542028

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Collaborators

  • PD Dr. med. Ferdinand Knieling, Department of pediatrics, University of Erlangen-Nürnberg

Registry information

Official study title

Multispectral Optoacoustic Tomography (MSOT) and Ultrasound Localization Microscopy (ULM) as Diagnostic Imaging for Lymphatic, Venous and Arteriovenous Malformations

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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