Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-24

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Vascular Diseases Peripheral Arterial Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Multispectral Optoacoustic Tomography (MSOT)

Intervention Type DEVICE

non-invasive transcutaneous imaging of subcellular muscle components

Interventions

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Multispectral Optoacoustic Tomography (MSOT)

non-invasive transcutaneous imaging of subcellular muscle components

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with manifest PAD stages II-IV according to Fontaine or healthy volunteers
* Adult (\>18 years) persons who are able to give their consent

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes