UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035398 |
|---|---|
| Receipt number | R000040333 |
| Scientific Title | Observation study of the changes of the skin temperature by venous injection of drugs using thermography |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2020/06/30 10:48:34 |
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Basic information
Public title
Observation study of the changes of the skin temperature by venous injection of drugs using thermography
Acronym
Observation study of the skin temperature by venous injection
Scientific Title
Observation study of the changes of the skin temperature by venous injection of drugs using thermography
Scientific Title:Acronym
Observation study of the skin temperature by venous injection
Region
| Japan |
Condition
Condition
The patients to whom the diagnostic or therapeutic radioisotope is injected.
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe the changes of the skin temperature by venous injection of radioisotope drugs using a very-high-sensitivity infrared thermographic camera
Basic objectives2
Others
Basic objectives -Others
The distribution of the changes of the skin temperature
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of the skin temperature by venous injection
Key secondary outcomes
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
We observe the changes of the skin temperature by venous injection of radioisotope drugs using a very-high-sensitivity infrared thermographic camera for several minutes.
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
The patients to whom radioisotope drugs are injected.
Key exclusion criteria
The patients who are judged as inappropriate person for participation in this examination by the doctor in charge
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsumasa Nakamura |
Organization
Hamamatsu University School of Medicine
Division name
Department of Radiation Oncology
Zip code
Address
Handayama 3-1-1, Higashi-ku, Hamamatsu 431-3192, JAPAN
TEL
053-435-2242
nakam@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsumasa Nakamura |
Organization
Hamamatsu University School of Medicine
Division name
Department of Radiation Oncology
Zip code
Address
Handayama 3-1-1, Higashi-ku, Hamamatsu 431-3192, JAPAN
TEL
053-435-2242
Homepage URL
nakam@hama-med.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2019 | Year | 01 | Month | 04 | 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 | 11 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the changes of the skin temperature by venous injection of radioisotope drugs using a very-high-sensitivity infrared thermographic camera for several minutes.
Management information
Registered date
| 2018 | Year | 12 | Month | 28 | Day |
Last modified on
| 2020 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040333
