Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
Lower extremity artery disease (LEAD) is characterized by low awareness rate and high missed diagnosis rate, leading to low treatment rate and high disabling mortality rate. However, none of the current examination methods can comprehensively and thoroughly evaluate the vascular structure and blood oxygen status of the lower extremity at the same time. Photoacoustic imaging can display millimeter-scale microvessels without the need for contrast agents. The investigators developed photoacoustic tomography (PACT) technology, which wass able to provide three-dimensional and high-resolution photoacoustic images of the target area.The investigators plan to recruit LEAD patients in different disease conditions and healthy volunteers to receive the PACT examination on the feet using this imaging system, and to evaluate the potential clinical role of the imaging system in LEAD, and its added value to current imaging methods.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Inclusion of the case group 1) LEAD patients; 2) Patients voluntarily take part in the study and write informed consent.
Inclusion of the control group 1) Patients without LEAD by ultrasound and clinical diagnosis; 2) Patients voluntarily take part in the study and write informed consent.
Disqualifiers
age <18 years;
pregnant women, nursing mothers and pregnant women in preparation;
with laser operation contraindication (for example, received a photodynamic therapy in the last month);
with metal implants in lower legs or feet;
Trial population
The LEAD patients are diagnosed as LEAD by computed tomography angiography or ultrasound.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Photoacoustic imaging
Diagnostic testIt could provide three-dimensional ultrasound images of vessels in the target area. It could also provides super-resolution and large-depth photoacoustic images. By effectively extracting photoacoustic spectral features and using spectral feature unmixing algorithm, blood oxygen saturation can be calculated.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Mean vessel density of foot vasculature measured by photoacoustic imaging
Vessel density (number of vessels per mm²) in foot vasculature will be quantified using photoacoustic imaging. Results will be reported as mean ± SD.
Time frame
BaselineSecondary outcomes
1
Mean oxygen saturation in pedal vasculature measured by photoacoustic imaging
Oxygen saturation in pedal vasculature will be quantified by photoacoustic imaging. Results will be reported as mean ± SD. Unit of Measure: %
Time frame
Baseline2
Mean hemoglobin concentration in pedal vasculature measured by photoacoustic imaging
Description: Hemoglobin concentration in pedal vasculature will be quantified by photoacoustic imaging. Results will be reported as mean ± SD. Unit of Measure: g/dL
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov