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An Exploratory Clinical Study for the Development of the Diagnostic Method for Vascular Lesions Using Photoacoustic Imaging (ECS-DDMMV-PAI)

A Clinical Study to Visualize Vessels Using Photoacoustic
Imaging (CS-VMV-PAI)

38

Subjects included 38 patients with suspected vascular abnormalities (Varicose veins, arteriosclerosis obliterans, vasculitis, Raynaud's syndrome, haemangiomas, vascular malformations) and diabetics. The mean age was 67.6 years, 24 were women and 14 were men.

Data for 18 of the cases performed were excluded due to non-compliance. Safety was investigated in the remaining 20 cases.

One adverse event not related to the study occurred. On 2 September 2022, 1 case of SAE (79-year-old woman, stroke).

Primary endpoint As the target number of cases was not reached, no statistical analysis of the data will be performed, but with the exception of one adverse event, there were no safety issues. Secondary endpoint Of the 20 cases analysed, 19 (95%) had good delineation at all sites where images were acquired. In general, vessels close to the sensor (shallow vessels in the body, vessels in areas where it was possible to approach the measurement surface) were well delineated. The ankle joint of one case of arteriosclerosis, where it was difficult to bring the measurement site close to the sensor and the area to be delineated was under pigmentation, was incompletely delineated, while the other imaging sites were well delineated. With the present method, the bifurcation was fairly clearly delineated in the three-dimensional running morphology, and it was easy to trace the three-dimensional running. In varicose veins, it was observed that the varicose areas had more tortuous vessels and increased vessel density, suggesting the possibility of quantification of the disease state. However, more cases are needed to determine efficacy. With regard to the vessel diameter of varicose veins, it is important to note that the diameter of meandering vessels tended to vary in thickness more than normal vessels, but was also affected by the depth of the vessel due to the characteristics of photoacoustic waves.

Although one of the 20 analysed cases had an SAE not in accordance with Article 13 of the Act, the other 19 cases did not show any adverse events and tended to be safe, but assuming a 10% incidence of adverse events, the number of cases required to detect at least one case with a 95% probability is 30 cases, and in this study the number of analysed cases was 20 Therefore, statistical conclusions could not be reached.

Dec. 31, 2024

https://pai.med.keio.ac.jp

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs032210555

Obara Hideaki

Keio University School of Medicine (Keio University Hospital)

35 Shinanomachi, Shinjuku-ku, Tokyo

obara.z3@keio.jp

Matsuda Sachiko

Keio University School of Medicine

35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-5363-3802

matsudasachiko@keio.jp

Complete

Jan. 18, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

parallel assignment

basic science

1. Patients aged 12 years to 85 years at the time of consent acquisition and suspected to have vascular disease, who are judged by their doctor that in a condition without any problems participating in the research.
2. Persons in accordance with criteria 1 who have agreed to participate in this study from their own free will with document consents.

1. Pregnancy or possible pregnancy.
2.The status of immunodeficiency due to neutropenia and so on.
3.Complications that make imaging difficult (e.g. inability to maintain the posture).
4.In cases where it is judged by the research director or the attending physician that it is inappropriate for carrying out this research (e.g. having trouble with the subject's physical condition by keeping the posture during the imaging).

Both

Varix, peripheral vascular disease, diabetes mellitus, vasculitis, Raynaud s syndrome, hemangioma, v

hotoacoustic imaging study

Vascular disease

Photoacoustic techniques

I839, E14, L959, I730, D180, Q279

D061088

Safety

The capability of the photoacoustic imaging system for visualizing the vascular lesion of the patients (The blood vessel, inner diameter, and three-dimensional running directions of the blood vessels are evaluated in three phases of evaluations which are inability to depict, incomplete depiction, and good depiction.)

+81-3-5363-3503

Nov. 30, 2021

none