UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014452 |
|---|---|
| Receipt number | R000016735 |
| Scientific Title | Clinical Study On Effectiveness Of Newly developed Radiation Diagnostic Apparatus Si/CdTe Compton Camera |
| Date of disclosure of the study information | 2014/07/02 |
| Last modified on | 2022/07/28 16:51:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical Study On Effectiveness Of Newly developed Radiation Diagnostic Apparatus Si/CdTe Compton Camera
Acronym
Radiation Diagnostic Study On Effectiveness Of Si/CdTe Compton Camera
Scientific Title
Clinical Study On Effectiveness Of Newly developed Radiation Diagnostic Apparatus Si/CdTe Compton Camera
Scientific Title:Acronym
Radiation Diagnostic Study On Effectiveness Of Si/CdTe Compton Camera
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this clinical study i sto assess the ability of simultaneous 3-dimaensinal imaging for clinical application of our newly developed Si/CdTe Compton camera and to get the basical data for optimizing its imaging ability with 99m-TC and PET reagent.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether nuclear imaging is obtained or not
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
Nuclear medical imaging by the Si/CdTl compton camera is performed from soon after Tc99m-DMSA and F18-FDG injection. The imaging is repeated 4 times with 15 minutes break in every 45 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
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
1) healthy person (normal liver and renal function)
2) no allergic history to 99mTc-DMSA and 18F-FDG
3) person who was informed consent and agreed to participate in this study with written document
Key exclusion criteria
1) person who was judged as unsuitable for this study by corresponding doctor
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
371-8511
Address
Showa-Machi 3-39-22, Maebashi City, Gunma Prefecture, Japan
TEL
027-220-8383
tnakano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
371-8511
Address
Showa-Machi 3-39-22, Maebashi City, Gunma Prefecture, Japan
TEL
027-220-8383
Homepage URL
syoshi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gunma University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital
Address
Showa-Machi 3-39-15, Maebashi, Gunma, Japan
Tel
027-220-8740
gunmaciru-office@umin.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
| 2014 | Year | 07 | Month | 02 | 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
| 2014 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation of adverse event is scheduled after the study on the next working day.
Management information
Registered date
| 2014 | Year | 07 | Month | 02 | Day |
Last modified on
| 2022 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016735
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
