Vascular MalformationNCT06994260
Diagnostic Imaging of Vascular Malformations Using MSOT and ULM
An observational study of Vascular Malformation and Arteriovenous Malformation, run by University Hospital Erlangen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Malformation, Arteriovenous Malformation, Lymphatic Malformation
- What is being tested?
- Multispectral Optoacoustic Tomography and Ultrasound Localization Microscopy
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients (≥18 years old) with diagnosed vascular malformations. These may be of lymphatic, venous, or arteriovenous origin.
Who may be able to join
- Confirmed vascular malformations (arteriovenous, venous, or lymphatic).
- ≥18 years old and able to give their consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Erlangen, Department of Vascular Surgery
Erlangen, Bavaria, 91054
Ulrich Rother, PD Dr. med., +4991318542028, ulrich.rother@uk-erlangen.de
Rabah F. Sankari
About this study
Official title: Multispectral Optoacoustic Tomography (MSOT) and Ultrasound Localization Microscopy (ULM) as Diagnostic Imaging for Lymphatic, Venous and Arteriovenous Malformations
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.
Read the detailed description
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.
- Conditions
- Vascular Malformation, Arteriovenous Malformation, Lymphatic Malformation, Venous Malformations
- Being tested
- Multispectral Optoacoustic Tomography, Ultrasound Localization Microscopy
- Keywords
- Vascular Malformation, Venous Malformation, Arteriovenous Malformation, Lymphatic Malformation, MSOT, ULM
- Medical subject headings
- Vascular Malformations, Arteriovenous Malformations, Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic TomographyDiagnostic 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 MicroscopyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Venous Malformation | Patients with venous malformations. Receives: Diagnostic Test: Multispectral Optoacoustic Tomography; Diagnostic Test: Ultrasound Localization Microscopy | |
| Arteriovenous Malformations | Patients with arteriovenous malformations. Receives: Diagnostic Test: Multispectral Optoacoustic Tomography; Diagnostic Test: Ultrasound Localization Microscopy | |
| Lymphatic Malformations | Patients with lymphatic malformations. Receives: Diagnostic Test: Multispectral Optoacoustic Tomography; Diagnostic Test: Ultrasound Localization Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative signal of total hemoglobin (HbT), oxygenated hemoglobin (HbO2), deoxygenated hemoglobin (Hb), and oxygen saturation (mSO2).
using MSOT
Measured: through study completion, an average of 1 year
Quantification of perfusion dynamics in the respective vessel.
using ULM
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vascular MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg
- Responsible party
- Principal investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994260
- Sponsor's protocol ID
- MSOT_ULM_malfo
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29217061Kansy 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.
PubMed 29609843Gray 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.
PubMed 29596084Dompmartin 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.
PubMed 20870869Demene 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.
PubMed 33723412Carqueja 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.
PubMed 29424187
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multispectral Optoacoustic Tomography (MSOT) and Ultrasound Localization Microscopy (ULM) as Diagnostic Imaging for Lymphatic, Venous and Arteriovenous Malformations
- ClinicalTrials.gov ID
- NCT06994260
- Acronym / sponsor ID
- MSOT_ULM_malfo
- Conditions
- Vascular Malformation, Arteriovenous Malformation, Lymphatic Malformation, Venous Malformations
- Keywords
- Vascular Malformation, Venous Malformation, Arteriovenous Malformation, Lymphatic Malformation, MSOT, ULM
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Venous Malformation | – | Diagnostic Test: Multispectral Optoacoustic Tomography, Diagnostic Test: Ultrasound Localization MicroscopyPatients with venous malformations. |
| Arteriovenous Malformations | – | Diagnostic Test: Multispectral Optoacoustic Tomography, Diagnostic Test: Ultrasound Localization MicroscopyPatients with arteriovenous malformations. |
| Lymphatic Malformations | – | Diagnostic Test: Multispectral Optoacoustic Tomography, Diagnostic Test: Ultrasound Localization MicroscopyPatients with lymphatic malformations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients (≥18 years old) with diagnosed vascular malformations. These may be of lymphatic, venous, or arteriovenous origin.
Key inclusion criteria (2 listed)
- Confirmed vascular malformations (arteriovenous, venous, or lymphatic).
- ≥18 years old and able to give their consent
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacoustic TomographyMSOT 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. | Diagnostic test | Arteriovenous Malformations, Lymphatic Malformations, Venous Malformation |
| Ultrasound Localization MicroscopyULM 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. | Diagnostic test | Arteriovenous Malformations, Lymphatic Malformations, Venous Malformation |
Primary outcome
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
Quantification of perfusion dynamics in the respective vessel.
Time frame: through study completion, an average of 1 year
using ULM
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 29217061Seront 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.
- Background: PubMed 29609843Kansy 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.
- Background: PubMed 29596084Gray 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.
- Background: PubMed 20870869Dompmartin 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.
- Background: PubMed 33723412Demene 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.
- Background: PubMed 29424187Carqueja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Malformation and Arteriovenous Malformation, run by University Hospital Erlangen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Rother, PD Dr. med. (+4991318542028, ulrich.rother@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994260, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.