UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009826 |
|---|---|
| Receipt number | R000011510 |
| Scientific Title | Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia |
| Date of disclosure of the study information | 2013/01/21 |
| Last modified on | 2023/07/31 12:44:14 |
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Basic information
Public title
Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia
Acronym
Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia
Scientific Title
Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia
Scientific Title:Acronym
Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia
Region
| Japan |
Condition
Condition
Interstitial pneumonia
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify whether dual-time-point 18F-FDG PET imaging is useful to predict treatment response in patients with interstitial pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival of pulmonary function tests after treatment initiation
Key secondary outcomes
Overall survival after treatment initiation
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
| Other |
Interventions/Control_1
Patients undergo Dual-time-point 18F-FDG PET within 1 month before treatment initiation and 1 month after treatment initiation. To evaluate short-term disease progression, patients undergo pulmonary function testing at least every 3 months for 1 year after treatment initiation.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients are men and women aged 18 years or older with a diagnosis of interstitial pneumonia.
Key exclusion criteria
Exclusion criteria;
1, Fasting serum glucose levels above 150 mg/dl.
2, Pregnant women.
3, Nursing women.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Umeda |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
0776-61-3111
umeda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Umeda |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
0776-61-3111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Biomedical Imaging Research Center, Faculty of Medical Sciences, Universtity of Fukui
Name of secondary funder(s)
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
福井大学医学部附属病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 21 | 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
| 2012 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011510
