Peripheral Vascular DiseasesNCT05110677
Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
An observational study of Peripheral Vascular Diseases and Peripheral Arterial Disease, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
The aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle. This study aims to show the feasibility of 3D reconstruction of this non-invasive method. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Diseases, Peripheral Arterial Disease
- What is being tested?
- Multispectral Optoacoustic Tomography (MSOT)
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- 24 Nov 2021to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with PAD IIa/IIb/III/IV according to Fontaine who come in for a routine presentation of the the vascular surgery consultation hours. Healthy volunteers with * no PAD previously known * no diabetes mellitus previously known * no chronic renal insufficiency previously known * no symptoms in the sense of a Claudicatio intermittens * ABI with normal value who are recruited by clinic notices.
Who may be able to join
- Patients with manifest PAD stages II-IV according to Fontaine or healthy volunteers
- Adult (>18 years) persons who are able to give their consent
Who cannot join
- Patients with PAD stage I according to Fontaine
- Healthy volunteers with pre-existing diabetes mellitus, chronic renal failure, or abnormal ABI
- Underage persons
- Missing consent form
- Exclusion due to safety concerns of the study physician (patient with a physical, mental or psychiatric illness which, in the opinion of the study physician, would compromise the safety of the patient or the quality of the data and thus make the patient an unsuitable candidate for the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Topographic Imaging of the Gastrocnemius Muscle in Patients With PAD Using Non-invasive Multispectral Optoacoustic Tomography (MSOT) as a 3D Reconstruction Based on Longitudinal 2D Measurements
The aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle. This study aims to show the feasibility of 3D reconstruction of this non-invasive method. Advantages in diagnostics for patients with PAD and three-dimensional tomography representation of the perfusion situation based on muscle oxygenation will be evaluated.
Read the detailed description
Functional imaging diagnostics is becoming increasingly important due to the steadily growing knowledge of physiological processes in many diseases. Also in peripheral arterial occlusive disease (PAD), new insights into the pathomechanism of the disease are continuously being gained. This also increases the need for new non-invasive imaging methods that are able to visualize the functional level of the disease progression and thus make it possible to diagnose it at an early stage.
Recent studies indicate that it may be feasible to use multispectral optoacoustic tomography (MSOT) to visualize hemodynamics as well as the fibrotic muscle remodeling process in PAD. For a better understanding of the distribution pattern , the exploration of a 3D technique is a next necessary step in imaging. This may show a possible existing heterogeneity of these molecules.
Holzwarth et al. were already able to gain knowledge about the 3D reconstruction from 2D photoacoustic image slices using an optical pattern and the method's feasibility using phantoms as well as in-vivo measurements of the forearm in healthy volunteers.
The aim of this exploratory pilot project is to bring these previous findings together and to image muscle perfusion of the lower extremity in three dimensions using the MSOT method and to verify its feasibility. The advantage of 3D imaging is, beyond the anatomical topography of the muscle, to map a three-dimensional representation of the perfusion situation based on muscle oxygenation.
For this purpose, six patients of different symptomatic PAD stages and a healthy control of two volunteers will be included and examined by means of longitudinal MSOT scans in the area of the gastrocnemius muscle. To evaluate the current stage of the disease or to exclude relevant PAD in the healthy control population, non-invasive examination measures commonly used in routine diagnostics of PAD will be applied. In addition to the relevant risk factors/adjacent diseases and the current medication intake, these include the recording of the ankle-brachial index (ABI), color-coded duplex sonographic vascular imaging (CCDS) and a treadmill examination.
- Being tested
- Multispectral Optoacoustic Tomography (MSOT)
- Keywords
- Peripheral Vascular Disease, Peripheral Arterial Disease, Multispectral Optoacoustic Tomography, MSOT, PAD, Claudicatio intermittens, Critical Limb Ischemia, CLI, Diagnostic imaging, Color-Coded Duplex Sonography, CCDS, Non-invasive diagnostic procedure, non-invasive diagnostic, noninvasive diagnostic, 3D imaging, three-dimensional imaging, three-dimensional diagnostic, 3D diagnostic, tattoo tomography, optical pattern
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic Tomography (MSOT)Device
non-invasive transcutaneous imaging of subcellular muscle components
| Study group | Role | What they receive |
|---|---|---|
| Study group | Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus gastrocnemius of the affected leg in PAD patients or one leg in healthy volunteers (total 1 site)
Physical assessment: Color-Coded Duplex Sonography/treadmill examination to determine actual walking distance/Ankle-Brachial-Index/defined walking distance of 150 meters under medical supervision Receives: Device: Multispectral Optoacoustic Tomography (MSOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSOT topogram showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle
MSOT topogram using 3D reconstruction based on longitudinal 2D scans trough an optical pattern showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle
Measured: single time point (1 day)
Secondary outcomes (10)
Acquisition of the quantitative hemoglobin signal (oxygenated/deoxygenated)
This Outcome is measured non-invasively by MSOT, the single wavelengths are spectrally unmixed
Measured: single time point (1 day)
Acquisition of the quantitative fibrosis signals (collagen/lipid)
This Outcome is measured non-invasively by MSOT, the single wavelengths are spectrally unmixed
Measured: single time point (1 day)
3D reconstruction of the longitudinal measurements using two different pattern designs
This Outcome is measured non-invasively by MSOT. A foil imprinted with an "N" is applied and fixed over the calf muscle. Three longitudinal 2D measurements are made or repeated until a promising result is obtained. The same procedure is repeated with a foil imprinted with a trident.
Measured: single time point (1 day)
Acquisition of static 2D MSOT measurements before and after gait exposure
This Outcome is measured non-invasively by MSOT. An initial measurement is taken at rest. Subsequently, the patient will complete a defined walking distance of 150 meters under medical supervision. Afterwards, the medial head of the gastrocnemius muscle is measured again.
Measured: single time point (1 day)
Validation of the accuracy of the MSOT 3D reconstruction using an overlay from MRA
This Outcome is only realized in participants who received an magnetic resonance angiography regardless of study participation
Measured: single time point (1 day)
Acquisition of the flow profile of the common femoral artery and popliteal artery using CCDS
This Outcome is measured non-invasively by standardized vascular sonography
Measured: single time point (1 day)
Acquisition of the Ankle-Brachial-Index
This Outcome is measured non-invasively by standardized clinical assessment according to the according to the recommendation from the S3 guideline for PAD of the German Association for Angiology ("Deutsche Gesellschaft für Angiologie") dated November 30, 2015
Measured: single time point (1 day)
Acquisition of the current walking distance standardized by treadmill examination
This Outcome is measured by a standardized treadmill examination (excluding PAD patients in chronic critical stage III or IV according to Fontaine) ideally with 3km/h and 12% incline
Measured: single time point (1 day)
Acquisition of the PAD stage according to Fontaine and Rutherford
This Outcome is acquired by actual recommendation from national and international guidelines
Measured: single time point (1 day)
Recording of relevant patient data from the patient's file
Preexisting disorders, previous performed operations on vessels, current medication, radiological TransAtlantic InterSociety Consensus classification
Measured: single time point (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start24 Nov 2021
- Primary completion31 Jan 2022
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Collaborators
- Division of Computer Assisted Medical Interventions, German Cancer Research Center, Heidelberg, Germany
- Responsible party
- Principal investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110677
- Sponsor's protocol ID
- MSOT_PAD_3D
- Status last verified
- Feb 2022
- First submitted
- 12 Oct 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Signorelli SS, Vanella L, Abraham NG, Scuto S, Marino E, Rocic P. Pathophysiology of chronic peripheral ischemia: new perspectives. Ther Adv Chronic Dis. 2020 Feb 5;11:2040622319894466. doi: 10.1177/2040622319894466. eCollection 2020.
PubMed 32076496Karlas A, Kallmayer M, Fasoula NA, Liapis E, Bariotakis M, Kronke M, Anastasopoulou M, Reber J, Eckstein HH, Ntziachristos V. Multispectral optoacoustic tomography of muscle perfusion and oxygenation under arterial and venous occlusion: A human pilot study. J Biophotonics. 2020 Jun;13(6):e201960169. doi: 10.1002/jbio.201960169. Epub 2020 Mar 25.
PubMed 32134550Holzwarth N, Schellenberg M, Grohl J, Dreher K, Nolke JH, Seitel A, Tizabi MD, Muller-Stich BP, Maier-Hein L. Tattoo tomography: Freehand 3D photoacoustic image reconstruction with an optical pattern. Int J Comput Assist Radiol Surg. 2021 Jul;16(7):1101-1110. doi: 10.1007/s11548-021-02399-w. Epub 2021 May 16.
PubMed 33993409
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Topographic Imaging of the Gastrocnemius Muscle in Patients With PAD Using Non-invasive Multispectral Optoacoustic Tomography (MSOT) as a 3D Reconstruction Based on Longitudinal 2D Measurements
- ClinicalTrials.gov ID
- NCT05110677
- Acronym / sponsor ID
- MSOT_PAD_3D
- Keywords
- Peripheral Vascular Disease, Peripheral Arterial Disease, Multispectral Optoacoustic Tomography, MSOT, PAD, Claudicatio intermittens, Critical Limb Ischemia, CLI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Collaborators
- Division of Computer Assisted Medical Interventions, German Cancer Research Center, Heidelberg, Germany
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 8 Nov 2021 (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.
The aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle. This study aims to show the feasibility of 3D reconstruction of this non-invasive method. Advantages in diagnostics for patients with PAD and three-dimensional tomography representation of the perfusion situation based on muscle oxygenation will be evaluated.
Detailed description
Functional imaging diagnostics is becoming increasingly important due to the steadily growing knowledge of physiological processes in many diseases. Also in peripheral arterial occlusive disease (PAD), new insights into the pathomechanism of the disease are continuously being gained. This also increases the need for new non-invasive imaging methods that are able to visualize the functional level of the disease progression and thus make it possible to diagnose it at an early stage.
Recent studies indicate that it may be feasible to use multispectral optoacoustic tomography (MSOT) to visualize hemodynamics as well as the fibrotic muscle remodeling process in PAD. For a better understanding of the distribution pattern , the exploration of a 3D technique is a next necessary step in imaging. This may show a possible existing heterogeneity of these molecules.
Holzwarth et al. were already able to gain knowledge about the 3D reconstruction from 2D photoacoustic image slices using an optical pattern and the method's feasibility using phantoms as well as in-vivo measurements of the forearm in healthy volunteers.
The aim of this exploratory pilot project is to bring these previous findings together and to image muscle perfusion of the lower extremity in three dimensions using the MSOT method and to verify its feasibility. The advantage of 3D imaging is, beyond the anatomical topography of the muscle, to map a three-dimensional representation of the perfusion situation based on muscle oxygenation.
For this purpose, six patients of different symptomatic PAD stages and a healthy control of two volunteers will be included and examined by means of longitudinal MSOT scans in the area of the gastrocnemius muscle. To evaluate the current stage of the disease or to exclude relevant PAD in the healthy control population, non-invasive examination measures commonly used in routine diagnostics of PAD will be applied. In addition to the relevant risk factors/adjacent diseases and the current medication intake, these include the recording of the ankle-brachial index (ABI), color-coded duplex sonographic vascular imaging (CCDS) and a treadmill examination.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Multispectral Optoacoustic Tomography (MSOT)Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus gastrocnemius of the affected leg in PAD patients or one leg in healthy volunteers (total 1 site) Physical assessment: Color-Coded Duplex Sonography/treadmill examination to determine actual walking distance/Ankle-Brachial-Index/defined walking distance of 150 meters under medical supervision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PAD IIa/IIb/III/IV according to Fontaine who come in for a routine presentation of the the vascular surgery consultation hours. Healthy volunteers with * no PAD previously known * no diabetes mellitus previously known * no chronic renal insufficiency previously known * no symptoms in the sense of a Claudicatio intermittens * ABI with normal value who are recruited by clinic notices.
Key inclusion criteria (2 listed)
- Patients with manifest PAD stages II-IV according to Fontaine or healthy volunteers
- Adult (>18 years) persons who are able to give their consent
Key exclusion criteria (5 listed)
- Patients with PAD stage I according to Fontaine
- Healthy volunteers with pre-existing diabetes mellitus, chronic renal failure, or abnormal ABI
- Underage persons
- Missing consent form
- Exclusion due to safety concerns of the study physician (patient with a physical, mental or psychiatric illness which, in the opinion of the study physician, would compromise the safety of the patient or the quality of the data and thus make 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 Tomography (MSOT)non-invasive transcutaneous imaging of subcellular muscle components | Device | Study group |
Primary outcome
MSOT topogram showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle
Time frame: single time point (1 day)
MSOT topogram using 3D reconstruction based on longitudinal 2D scans trough an optical pattern showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle
10 secondary outcomes
Acquisition of the quantitative hemoglobin signal (oxygenated/deoxygenated)
Time frame: single time point (1 day)
Acquisition of the quantitative fibrosis signals (collagen/lipid)
Time frame: single time point (1 day)
3D reconstruction of the longitudinal measurements using two different pattern designs
Time frame: single time point (1 day)
Acquisition of static 2D MSOT measurements before and after gait exposure
Time frame: single time point (1 day)
Validation of the accuracy of the MSOT 3D reconstruction using an overlay from MRA
Time frame: single time point (1 day)
Acquisition of the flow profile of the common femoral artery and popliteal artery using CCDS
Time frame: single time point (1 day)
Acquisition of the Ankle-Brachial-Index
Time frame: single time point (1 day)
Acquisition of the current walking distance standardized by treadmill examination
Time frame: single time point (1 day)
Acquisition of the PAD stage according to Fontaine and Rutherford
Time frame: single time point (1 day)
Recording of relevant patient data from the patient's file
Time frame: single time point (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Background: PubMed 32076496Signorelli SS, Vanella L, Abraham NG, Scuto S, Marino E, Rocic P. Pathophysiology of chronic peripheral ischemia: new perspectives. Ther Adv Chronic Dis. 2020 Feb 5;11:2040622319894466. doi: 10.1177/2040622319894466. eCollection 2020.
- Background: PubMed 32134550Karlas A, Kallmayer M, Fasoula NA, Liapis E, Bariotakis M, Kronke M, Anastasopoulou M, Reber J, Eckstein HH, Ntziachristos V. Multispectral optoacoustic tomography of muscle perfusion and oxygenation under arterial and venous occlusion: A human pilot study. J Biophotonics. 2020 Jun;13(6):e201960169. doi: 10.1002/jbio.201960169. Epub 2020 Mar 25.
- Background: PubMed 33993409Holzwarth N, Schellenberg M, Grohl J, Dreher K, Nolke JH, Seitel A, Tizabi MD, Muller-Stich BP, Maier-Hein L. Tattoo tomography: Freehand 3D photoacoustic image reconstruction with an optical pattern. Int J Comput Assist Radiol Surg. 2021 Jul;16(7):1101-1110. doi: 10.1007/s11548-021-02399-w. Epub 2021 May 16.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Peripheral Vascular Diseases and Peripheral Arterial Disease, 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 5 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSOT topogram showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle (time frame: single time point (1 day)). 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 NCT05110677, which also lists 3 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 21 Feb 2022.