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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028645
Receipt No. R000032723
Scientific Title Test-retest reliability of a quantitative bone SPECT/CT
Date of disclosure of the study information 2017/09/01
Last modified on 2019/08/14

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Basic information
Public title Test-retest reliability of a quantitative bone SPECT/CT
Acronym Test-retest reliability of a quantitative bone SPECT/CT
Scientific Title Test-retest reliability of a quantitative bone SPECT/CT
Scientific Title:Acronym Test-retest reliability of a quantitative bone SPECT/CT
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate test-retest reliability of the quantitative value measured by quantitative bone SPECT/CT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes test-retest reliability
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 Bone scintigraphy and SPECT/CT
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
Key inclusion criteria #1 Written informed consent was acquired
#2 Twenty years or older
#3 Prostate cancer was diagnosed or suspected
#4 Bone scintigraphy was performed or planned
#5 Second bone scintigraphy can be performed in 4-10 days after the first bone scan numbered #4
Key exclusion criteria #1 Unable to keep supine position for 1 hour
#2 Anti-cancer drug, hormone drug, radionuclide treatment or radiation therapy for bone lesion was planned during 2 bone scans
#3 Person in charge considered inappropriate to include to this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomohiko
Middle name
Last name Yamane
Organization Saitama Medical University International Medical Center
Division name Nuclear Medicine
Zip code 3501298
Address Yamane 1397-1, Hidaka
TEL 042-984-4111
Email yamane_t@saitama-med.ac.jp

Public contact
Name of contact person
1st name Yamane
Middle name
Last name Tomohiko
Organization Saitama Medical University International Medical Center
Division name Nuclear Medicine
Zip code 3501298
Address Yamane 1397-1, Hidaka
TEL 042-984-4111
Homepage URL
Email yamane_t@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University International Medical Center
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 Saitama Medical University International Medical Center IRB
Address Yamane 1397-1, Hidaka
Tel 042-984-4111
Email chikens@saitama-med.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
2017 Year 09 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
2017 Year 09 Month 06 Day
Anticipated trial start date
2017 Year 09 Month 30 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 12 Day
Last modified on
2019 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032723

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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