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

NCT05110677 | Unknown

• 1 other identifier: MSOT_PAD_3D
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  single time point (1 day)

Secondary Outcomes (10)

• Acquisition of the quantitative hemoglobin signal (oxygenated/deoxygenated)

  single time point (1 day)

• Acquisition of the quantitative fibrosis signals (collagen/lipid)

  single time point (1 day)

• 3D reconstruction of the longitudinal measurements using two different pattern designs

  single time point (1 day)

• Acquisition of static 2D MSOT measurements before and after gait exposure

  single time point (1 day)

• Validation of the accuracy of the MSOT 3D reconstruction using an overlay from MRA

  single time point (1 day)

Study Arms (1)

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

Device: Multispectral Optoacoustic Tomography (MSOT)

Interventions

Multispectral Optoacoustic Tomography (MSOT) DEVICE

non-invasive transcutaneous imaging of subcellular muscle components

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Erlangen: lead
• Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen, Erlangen, Germany: collaborator
• Division of Computer Assisted Medical Interventions, German Cancer Research Center, Heidelberg, Germany: collaborator

Study Sites (1)

University of Erlangen, Vascular Surgery

Erlangen, 91054, Germany

Location

Related Publications (3)

• 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.

  PMID: 32076496 BACKGROUND

• 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.

  PMID: 32134550 BACKGROUND

• 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.

  PMID: 33993409 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 8, 2021
• Study Start: November 24, 2021
• Primary Completion: January 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)