Diagnostic Imaging of Vascular Malformations Using MSOT and ULM

ConditionsVascular Malformation Arteriovenous Malformation Lymphatic Malformation Venous Malformations

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Hospital Erlangen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed vascular malformations (arteriovenous, venous, or lymphatic).

≥18 years old and able to give their consent

Disqualifiers

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).

Trial population

The study population consists of patients (≥18 years old) with diagnosed vascular malformations. These may be of lymphatic, venous, or arteriovenous origin.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

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.

Treatment groups

15 Participants

are divided into 3 treatment groups

Group A: Venous Malformation2 interventions

Group B: Arteriovenous Malformations2 interventions

Group C: Lymphatic Malformations2 interventions

Trial outcomes

Primary outcomes

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

using MSOT

Time frame

through study completion, an average of 1 year

Quantification of perfusion dynamics in the respective vessel.

using ULM

Time frame

through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Erlangen

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: