UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031310 |
|---|---|
| Receipt number | R000035209 |
| Scientific Title | Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion: comparison with the ultrasonography |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2019/03/13 09:34:28 |
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Basic information
Public title
Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion: comparison with the ultrasonography
Acronym
Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion
Scientific Title
Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion: comparison with the ultrasonography
Scientific Title:Acronym
Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion
Region
| Japan |
Condition
Condition
superficial lesion
Classification by specialty
| Dermatology | Radiology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ability to depict superficial tissue and lesion with the photoacoustic imaging
Basic objectives2
Others
Basic objectives -Others
To explore the utility of the photoacoustic imaging for superficial lesion
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subjective and objective evaluation of the photoacoustic imaging
Key secondary outcomes
1) The association between the photoacoustic images and other images except for conventional ultrasonography
2) The association between the the characteristics of the examinees and the photoacoustic images
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional ultrasonography
Interventions/Control_2
Photoacoustic imaging device
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 or patients with superficial lesion, aged 20 years or older at the time of consent acquisition.
2) Subjects who have agreed to participate in this study from their own free will with document consents.
Key exclusion criteria
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 the research director or the attending physician judges that conducting this research is inappropriate (e.g. hemorrhage or effusion from superficial lesion).
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Jinzaki |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL
03-3353-1977(+81-3-3353-1977)
jinzaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Narita |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL
03-3353-1977(+81-3-3353-1977)
Homepage URL
narit@rad.med.keio.ac.jp
Sponsor or person
Institute
Department of Radiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Canon Inc.
Hitachi, Ltd.
IRB Contact (For public release)
Organization
Address
Tel
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 | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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 | 02 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 13 | 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 | 02 | Month | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035209
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
