UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005010 |
|---|---|
| Receipt number | 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 09:58:05 |
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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
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
utateish@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Radiology, Yokohama City University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005955
