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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014452
Receipt No. 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 2014/07/04

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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 Single blind -participants are 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
Middle name
Last name Yoshiyuki Suzuki
Organization Gunma University Graduate School of Medicine
Division name Department of Radiation Oncology
Zip code
Address Showa-Machi 3-39-22, Maebashi City, Gunma Prefecture, Japan
TEL 027-220-8383
Email tnakano@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Suzuki
Organization Gunma University Graduate School of Medicine
Division name Department of Radiation Oncology
Zip code
Address Showa-Machi 3-39-22, Maebashi City, Gunma Prefecture, Japan
TEL 027-220-8383
Homepage URL
Email syoshi@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Gunma University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2014 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 26 Day
Last follow-up date
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
2014 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.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


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