Diagnostic Imaging of Vascular Malformations Using MSOT and ULM

NCT06994260 | Not Yet Recruiting

• 1 other identifier: MSOT_ULM_malfo
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Malformation; Arteriovenous Malformation; Lymphatic Malformation; Venous Malformations

Keywords

Vascular Malformation; Venous Malformation; Arteriovenous Malformation; Lymphatic Malformation; MSOT; ULM

Outcome Measures

Primary Outcomes (2)

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

  using MSOT

  through study completion, an average of 1 year

• Quantification of perfusion dynamics in the respective vessel.

  using ULM

  through study completion, an average of 1 year

Study Arms (3)

Venous Malformation

Patients with venous malformations.

Diagnostic Test: Multispectral Optoacoustic Tomography; Diagnostic Test: Ultrasound Localization Microscopy

Arteriovenous Malformations

Patients with arteriovenous malformations.

Diagnostic Test: Multispectral Optoacoustic Tomography; Diagnostic Test: Ultrasound Localization Microscopy

Lymphatic Malformations

Patients with lymphatic malformations.

Diagnostic Test: Multispectral Optoacoustic Tomography; Diagnostic Test: Ultrasound Localization Microscopy

Interventions

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.

Arteriovenous Malformations; Lymphatic Malformations; Venous Malformation

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.

Arteriovenous Malformations; Lymphatic Malformations; Venous Malformation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Erlangen: lead
• PD Dr. med. Ferdinand Knieling, Department of pediatrics, University of Erlangen-Nürnberg: collaborator

Study Sites (1)

University Hospital Erlangen, Department of Vascular Surgery

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (6)

• Seront E, Vikkula M, Boon LM. Venous Malformations of the Head and Neck. Otolaryngol Clin North Am. 2018 Feb;51(1):173-184. doi: 10.1016/j.otc.2017.09.003.

  PMID: 29217061 BACKGROUND

• Kansy K, Bodem J, Engel M, Freudlsperger C, Mohlenbruch MA, Herweh C, Bendszus M, Hoffmann J, Kargus S. Interdisciplinary treatment algorithm for facial high-flow arteriovenous malformations, and review of the literature. J Craniomaxillofac Surg. 2018 May;46(5):765-772. doi: 10.1016/j.jcms.2018.03.002. Epub 2018 Mar 9.

  PMID: 29609843 BACKGROUND

• Gray RL, Ortiz RA, Bastidas N. Combined Surgery and Intraoperative Sclerotherapy for Vascular Malformations of the Head/Neck: The Hybrid Approach. Ann Plast Surg. 2018 Apr;80(4 Suppl 4):S156-S157. doi: 10.1097/SAP.0000000000001366.

  PMID: 29596084 BACKGROUND

• Dompmartin A, Vikkula M, Boon LM. Venous malformation: update on aetiopathogenesis, diagnosis and management. Phlebology. 2010 Oct;25(5):224-35. doi: 10.1258/phleb.2009.009041.

  PMID: 20870869 BACKGROUND

• Demene C, Robin J, Dizeux A, Heiles B, Pernot M, Tanter M, Perren F. Transcranial ultrafast ultrasound localization microscopy of brain vasculature in patients. Nat Biomed Eng. 2021 Mar;5(3):219-228. doi: 10.1038/s41551-021-00697-x. Epub 2021 Mar 15.

  PMID: 33723412 BACKGROUND

• Carqueja IM, Sousa J, Mansilha A. Vascular malformations: classification, diagnosis and treatment. Int Angiol. 2018 Apr;37(2):127-142. doi: 10.23736/S0392-9590.18.03961-5. Epub 2018 Feb 8.

  PMID: 29424187 BACKGROUND

MeSH Terms

Conditions

Vascular Malformations; Arteriovenous Malformations; Lymphatic Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ulrich Rother, PD Dr. med.

CONTACT

+4991318542028; ulrich.rother@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Department of Vascular Surgery, University Hospital Erlangen

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

DE (1)