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An Exploratory Clinical Study for The Development of the Diagnostic Method for vascular Lesions Using Photoacoustic Imaging (ECS-DDMVL-PAI)

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

23

Sex Age (years) Healthy or Patient M 85 Patient F 73 Patient F 81 Patient F 80 Patient F 81 Patient M 25 Patient M 62 Patient F 51 Patient F 66 Healthy F 53 Patient F 23 Healthy M 69 Patient M 72 Patient F 77 Patient M 78 Patient M 71 Patient F 80 Patient F 81 Patient F 81 Patient F 78 Patient F 50 Healthy F 48 Patient F 50 Healthy

This was an exploratory study, and a total of 23 healthy subjects and patients with vascular lesions were examined.

Occurrence of diseases related to the clinical study and its progress Implementation date: April 25, 2018 A patient who was suspected to have lymphedema and a micro-arteriovenous shunt was hospitalized on April 25, 2018 for angiography and embolization by plastic surgery. Photoacoustic imaging (PAI) was started around 12:00 on the same day, but the PAI operator was unaware of the presence of cellulitis. (The patient s body temperature at hospitalization was 36.5 degrees Celsius, and he did not complain of any problems from the beginning to end of the imaging procedure. Although swelling and redness of the affected limb were observed, the patient reported that it was the same as usual.) After the PAI, the patient returned to the ward on his own and prepared for the angiography procedure (securement of a peripheral venous route, insertion of an indwelling bladder catheter, and intramuscular injection of a sedative), which was the main purpose of hospitalization. During this time, the presence of cellulitis was unnoticed by other medical personnel. The patient was transferred to the angiography suite for examination at around 16:00, and his body temperature was found to be 40 degrees Celsius with cellulitis extending from the affected limb to the abdomen. The patient s family later reported that he had had a fever and pain in the affected limb for a few days, but the medical staff had not been informed because the patient did not have a fever on the day of hospitalization. The next day (April 26), he was examined by a dermatologist, and medication for herpes zoster was started because herpes infection could not be ruled out as the cause of the abdominal rash. The patient was diagnosed with cellulitis caused by lymphedema of the lower extremities. The angiography procedure was postponed, and treatment of cellulitis by administration of antibiotics was started. Blood testing showed that his white blood cell count was 8200/uL and C-reactive protein concentration was 23.76 mg/L immediately after SAE (April 25), and these values decreased to 6200/uL and 19.98 mg/L the next morning (April 26), respectively. *After a dermatological examination on April 26, treatment of herpes zoster with antiviral drugs was started. *No fever was observed on April 28, and the abdominal rash was improved. *Blood testing on April 29 showed a white blood cell count of 8500/uL and C-reactive protein concentration of 13.99 mg/L. *Blood culture results on April 25 and May 1 were negative. *After a dermatological examination on May 2, the patient was discharged on May 3. Evaluation of safety and scientific validity of clinical study Based on the patient s medical history, it seemed that the symptoms of cellulitis had appeared before hospitalization. Because the fever had diurnal variation in the early stage after its onset, the fever had relieved and the patient s symptoms had improved at the time of PAI. Therefore, PAI was performed without the medical staff having noticed the presence of cellulitis, and the symptoms recurred thereafter. In this case, instead of PAI having caused the disease, we considered that the patient originally had the disease before hospitalization; thus, the effect of PAI is limited. In addition, all patients medical histories, general conditions, and lower limb symptoms were more thoroughly examined after this incident. No SAE was observed in the other patients. Based on the above, we determined that there is no problem with the safety and scientific validity of this study.

The primary endpoint (drawing ability) was accomplished by all 23 patients. The secondary endpoint (relationship with existing inspections) is being analyzed.

The primary endpoint (drawing ability) was accomplished by all 23 patients. The secondary endpoint (relationship with existing inspections) is being analyzed.

May. 01, 2021

No

Not applicable

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180341

Obara Hideaki

Keio University School of Medicine

35 Shinanomachi Shinjuku Ward Tokyo Japan

obara.z3@keio.jp

Kurahashi Akemi

Keio University School of Medicine

35 Shinanomachi Shinjuku Ward Tokyo Japan

+81-3-3353-3744

a-kurahashi@a6.keio.jp

Complete

Dec. 25, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

parallel assignment

basic science

1. Patients aged 20 years or older 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. Healthy persons aged 20 years or older at the time of consent acquisition without mental illness, dementia, who are judged by the doctor in charge that in a condition without any problems participating in the research.
3. Persons in accordance with criteria 1 or 2 who have agreed to participate in this study from their own free will with document consents.

1. Pregnancy or possible pregnancy.
2. Who has a skin lesion which a specialist diagnosed not to be irradiated.
3.Prohibited to use together, such as pacemaker, defibrillator, tattoo and so on.
4.The status of immunodeficiency due to neutropenia and so on.
5.Complications that make imaging difficult (e.g. inability to maintain the posture).
6.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

vascular disease

photoacoustic imaging study

-

-

The capability of the photoacoustic imaging system for visualizing the vascular Lesions of the patients

1. The relationship between the photoacoustic images and the images by other modalities
2. The relationship between the characteristics of the examinees and the photoacoustic images.

+81-3-5363-3503

Mar. 11, 2019

none