UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030925 |
|---|---|
| Receipt number | R000035270 |
| Scientific Title | An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/03/13 17:16:59 |
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Basic information
Public title
An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system
Acronym
An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system
Scientific Title
An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system
Scientific Title:Acronym
An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system
Region
| Japan |
Condition
Condition
Healthy volunteer, breast cancer
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate appropriate imaging conditions and imaging processing settings for optimal visualization of trunk perforating arteries using a new photoacoustic imaging system and to evaluate diagnostic potential of the system by comparing with other imaging modalities
Basic objectives2
Others
Basic objectives -Others
Anatomical investigation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spatial resolution (full width at half maximum, FWHM), penetration depth limit
Key secondary outcomes
Anatomical findings (location, depth, direction and brunching pattern of perforators)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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)
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy volunteers without vascular diseases or patients with breast cancer whose health condition does not limit the examination
2. Aged 20 years or older at the time of the informed consent
Key exclusion criteria
1. Pregnant and lactating women
2. People who takes photosensitizer for photodynamic therapy
3. People with a cardiac pacemaker
4. People with greater than or equal to class 4 (People with severe systemic disease that is a constant threat to life)
in ASA-PS (American Society of Anesthesiologists physical status classification)
5. People who have any following complications
Infections of the evaluation region
Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position
6. People who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators due to communication difficulty, limitations in taking examination position and other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masakazu, Susumu |
| Middle name | |
| Last name | Toi, Saito |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Breast Surgery, Plastic and Reconstructive Surgery
Zip code
606-8507
Address
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL
075-751-3613
susumus@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hanako |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Breast Surgery
Zip code
606-8507
Address
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL
075-751-3660
Homepage URL
hanako87@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University, Department of Breast Surgery, Plastic and Reconstructive Surgery
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Canon Inc.
Hitachi, Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital Ethics Committe
Address
Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Tel
0757534680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
57
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035270
