Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease

NCT06579326 | Recruiting

• 1 other identifier: II2024-189-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Extremity; Photoacoustic

Outcome Measures

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.

  Baseline

Secondary Outcomes (2)

• Mean oxygen saturation in pedal vasculature measured by photoacoustic imaging

  Baseline

• Mean hemoglobin concentration in pedal vasculature measured by photoacoustic imaging

  Baseline

Interventions

Photoacoustic imaging DIAGNOSTIC_TEST

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.

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

The LEAD patients are diagnosed as LEAD by computed tomography angiography or ultrasound.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Central Study Contacts

Jia Liu, Doctor

CONTACT

8602085252010; liujia45@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 30, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2025-08

Locations

CN (1)