UMIN-CTR Clinical Trial

Public title

An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.

Acronym

An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.

Scientific Title

An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.

Scientific Title:Acronym

An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.

Region

Japan

Condition

Patients with peripheral circulatory disturbance
Healthy volunteers

Classification by specialty

Surgery in general	Vascular surgery	Radiology
Plastic surgery	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To study safety and visualization capabilities of blood vessels in the extremities by using a photoacoustic imaging system.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Visualization capabilities of blood vessels in the extremities by using a photoacoustic imaging system.

Key secondary outcomes

Comparison between photo acoustic images and images of other modality

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Photoacoustic Imaging
(Duration of the device use is for one day, but in the judgment of principle investigator or subinvestigator, additional multi-day examination and multiple examination are conducted on different days. Also multiple scan is conducted in each use of the device, so total number of scans may be estimated to reach into a few dozen times)

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy volunteers or patients with peripheral circulatory disorders who aged over 20 years and older at the time of informed consent

2. The subjects who have agreed to participate in this study from their own free will with document consents

Key exclusion criteria

1. People who are pregnancy, suspicion of pregnancy.
2. People who have skin disorder that is not suitable for this trial judging by specialist.
3. People with cardiac pacemakers, defibrillator, and /or tattoo.
4. People with immunodeficiency such as leukopenia.
5. People who have complications that make them impossible to try photoacoustic imaging system.
6. People who are judged ineligible to enroll into this clinical study due to limitations in taking examination position by the investigator or the sub-investigators.

Target sample size

100

Name of lead principal investigator

1st name	Hideaki
Middle name
Last name	Obara

Organization

Keio University

Division name

Department of Surgery

Zip code

160-8582

Address

35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN

TEL

03-5363-3802

Email

obara@z3.keio.jp

Name of contact person

1st name	Hideaki
Middle name
Last name	Obara

Organization

Keio University

Division name

Department of Surgery

Zip code

160-8582

Address

35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN

TEL

03-5363-3802

Homepage URL

Email

obara@z3.keio.jp

Institute

Keio University School of medicine

Institute

Department

Personal name

Organization

Cabinet Office

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Certified Review Board of Keio

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

03-5363-3503

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

23

Results

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

Results date posted

2021

Year

11

Month

04

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

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

Participant flow

Adverse events

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.

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

09

Month

08

Day

Date of IRB

2017

Year

12

Month

20

Day

Anticipated trial start date

2017

Year

11

Month

13

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

2021

Year

03

Month

31

Day

Date trial data considered complete

2021

Year

03

Month

31

Day

Date analysis concluded

2022

Year

12

Month

20

Day

Other related information

Registered date

2017

Year

11

Month

01

Day

Last modified on

2021

Year

11

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032045