UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016735