Clinical trial NCT05110677: Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Vascular Diseases
Peripheral Arterial Disease
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
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
Collaborators: name: Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen, Erlangen, Germany
name: Division of Computer Assisted Medical Interventions, German Cancer Research Center, Heidelberg, Germany
First posted: 2021-11-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: MSOT topogram showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle
timeFrame: single time point (1 day)
Secondary outcomes:
measure: Acquisition of the quantitative hemoglobin signal (oxygenated/deoxygenated)
timeFrame: single time point (1 day)
measure: Acquisition of the quantitative fibrosis signals (collagen/lipid)
timeFrame: single time point (1 day)
measure: 3D reconstruction of the longitudinal measurements using two different pattern designs
timeFrame: single time point (1 day)
measure: Acquisition of static 2D MSOT measurements before and after gait exposure
timeFrame: single time point (1 day)
measure: Validation of the accuracy of the MSOT 3D reconstruction using an overlay from MRA
timeFrame: single time point (1 day)
measure: Acquisition of the flow profile of the common femoral artery and popliteal artery using CCDS
timeFrame: single time point (1 day)
measure: Acquisition of the Ankle-Brachial-Index
timeFrame: single time point (1 day)
measure: Acquisition of the current walking distance standardized by treadmill examination
timeFrame: single time point (1 day)
measure: Acquisition of the PAD stage according to Fontaine and Rutherford
timeFrame: single time point (1 day)
measure: Recording of relevant patient data from the patient's file
timeFrame: single time point (1 day)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen, Vascular Surgery
Study officials:
References:
citation: 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.
citation: Karlas 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.
citation: Holzwarth 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.