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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005010
Receipt No. R000005955
Scientific Title Research for validation of breath-hold PET/CT
Date of disclosure of the study information 2011/05/01
Last modified on 2013/08/02

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Basic information
Public title Research for validation of breath-hold PET/CT
Acronym Breath-hold PET
Scientific Title Research for validation of breath-hold PET/CT
Scientific Title:Acronym Breath-hold PET
Region
Japan

Condition
Condition pulmonary disorders
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to clarify the validity of breath-hold PET/CT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reproducibility, diagnostic accuracy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Patients with pulmonary disorders who underwent breath-hold PET/CT
Interventions/Control_2 Subjects who underwent breath-hold PET/CT as normal control
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
18 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients with pulmonary disorders who underwent breath-hold PET/CT and normal control.
Pathologic or clinical diagnosis is obtained.
Capability of breath-hold during examination.
Key exclusion criteria Diabetes
Pregnancy
Poor performance status
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ukihide Tateishi
Organization Yokohama City University
Division name Department of Radiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2696
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ukihide Tateishi
Organization Yokohama City University
Division name Department of Radiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2696
Homepage URL
Email utateish@yokohama-cu.ac.jp

Sponsor
Institute Department of Radiology, Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Department of Radiology, Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center
Name of secondary funder(s) Tokyo Medical Dental University

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 横浜市立大学医学部(神奈川県)、国立がん研究センター(東京都)、東京医科歯科大学医学部(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 05 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
Confirmation of reproducibility
Improvement of diagnostic accuracy
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
2004 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 01 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 02 Day
Last modified on
2013 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005955

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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