Photoacoustic Imaging of Atherosclerotic Plaques

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-02

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Stroke is a major cause of death and disability worldwide. Stenotic carotid arteries can lead to stroke if the cause of the stenosis is a vulnerable atherosclerotic plaque. Recent studies reveal that if a patient has a plaque in the carotid artery it is highly probable that he/she will develop plaques in other superficial arteries like the femoral artery. Currently, duplex ultrasound is used to determine the grade of stenosis and is the main criterion for intervention (endarterectomy) planning. However, the stability, or instability of the plaque cannot be determined non-invasively. Photoacoustics is a novel, non-invasive imaging modality that uses pulsed laser light to generate laser induced ultrasound in the absorbing region of the tissue. Photoacoustic imaging provides optical contrast of biological tissue chromophores with an acoustic resolution and imaging depth, which is promising for visualization of plaque composition. The advantage of photoacoustics is the use of multiple wavelengths, since different tissues respond differently to different wavelengths. Hence, non-invasive, in vivo, morphology assessment is a future application of this new modality that would improve diagnosis and clinical decision making. The drawback is the limited penetration depth of the laser light and the signals generated by surrounding tissue.

A new, integrated photoacoustic device has been developed that meets all safety requirements and has an improved penetration depth, suitable for imaging of carotid arteries with the aim to distinguish between plaques with different morphology.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasound Elastography for Individual Carotid Plaque Stratification

NCT05029661

Carotid Artery Plaque

UNKNOWN

Ultrafast Ultrasound Imaging Assesment of Carotid Plaque Neovascularization

NCT04470687

Carotid Stenosis Carotid Artery Diseases Carotid Atherosclerosis +2 more

COMPLETED NA

Ultrasound and Other Images of Artery Blockages

NCT01419574

Atherosclerosis

TERMINATED

Reproducibility Study of Transcranial Doppler

NCT03050567

Stroke

COMPLETED

Carotid Plaque Assessment Using 18Fluorine (18F) -Sodium Fluoride Positron Emission Tomography (PET) /MR

NCT02726984

Carotid Artery Plaque

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: The aim of this study is to investigate the feasibility of atherosclerotic plaque imaging using multispectral photoacoustic imaging.

Study design: This is a pilot study where 60 patients with a plaque in one of the carotids, scheduled for an endarterectomy procedure, will be included. Each subject will get a multi-wavelength photoacoustic examination of the carotid plaque. In one group (N = 30), photoacoustic imaging will be performed noninvasively at the TU/e laser lab, which is compliant with laser safety standards, to verify non-invasive, multi-angle, multi-wavelength photoacoustic imaging (Study A). In the second group (N = 30), photoacoustic imaging will be performed pre- and per-operatively (Study B) prior to plaque removal. Here, to ensure a 100% (laser) safe environment, all acquisitions will be performed in the operating theatre. The latter group will be subjected to additional Magnetic Resonance Imaging for validation. After carotid endarterectomie the plaque sample of each patient (Study A and B) will be transported to TU/e for in vitro PA scanning and histology analysis.

Study population: A total of 60 patients with carotid artery disease scheduled for endarterectomy (stenosis grade of \> 70% and \< 99%).

Intervention (if applicable): endarterectomy (following normal procedure), with an additional photoacoustic image acquisition after incision, before removal of the plaque.

Main study parameters/endpoints: The acoustic (i.e., echographic) and photoacoustic images will be analyzed to determine the ability of distinguishing between different plaque components (intraplaque hemorrhage, lipid pool, vessel wall), examine penetration depth, resolution, and contrast.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Artery Plaque

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with carotid artery stenosis

In this study, patients in the age of \> 18 year will be included that are scheduled for an endarterectomy procedure at CZE.

Photoacoustic imaging

Intervention Type DIAGNOSTIC_TEST

Photoacoustic imaging

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Photoacoustic imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

In order to be eligible to participate in this study, a subject must be an adult that is fully competent to give informed consent that has been under surveillance for a plaque in one of the carotid arteries with a stenosis grade between 70 and 99% (based on prior Duplex US examination in the vascular lab) In case of study A, the subject should physically be able to be seated in a chair without moving for 10 to 20 minutes.