RecruitingNCT06579326

Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease

Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease


Sponsor

Sun Yat-sen University

Enrollment

200 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria2

  • 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.

Exclusion Criteria6

  • 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;
  • with a history of mental illnesses or abuse of drug and alcohol;
  • \) with blood phobia or pathological hypotension; 8) with cerebral hemorrhage or peripheral vascular bleeding risk, or history of stroke; 9) with wounds in lower legs or feet; 10) unable or uncooperative with the experimenter.

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Interventions

DIAGNOSTIC_TESTPhotoacoustic imaging

It 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.


Locations(1)

the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06579326


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