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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035398
Receipt No. R000040333
Official scientific title of the study 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 2018/12/28

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Basic information
Official scientific title of the study Observation study of the changes of the skin temperature by venous injection of drugs using thermography
Title of the study (Brief title) 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 Katsumasa Nakamura
Organization Hamamatsu University School of Medicine
Division name Department of Radiation Oncology
Address Handayama 3-1-1, Higashi-ku, Hamamatsu 431-3192, JAPAN
TEL 053-435-2242
Email nakam@hama-med.ac.jp

Public contact
Name of contact person Katsumasa Nakamura
Organization Hamamatsu University School of Medicine
Division name Department of Radiation Oncology
Address Handayama 3-1-1, Higashi-ku, Hamamatsu 431-3192, JAPAN
TEL 053-435-2242
Homepage URL
Email nakam@hama-med.ac.jp

Sponsor
Institute Department of Radiation Oncology, Hamamatsu University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 02 Day
Anticipated trial start date
2019 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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