UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005197 |
|---|---|
| Receipt number | R000006174 |
| Scientific Title | Usefullness of thoracic MRI in the management of lung cancer -comparison with FDG-PET- |
| Date of disclosure of the study information | 2011/03/07 |
| Last modified on | 2013/09/05 09:45:20 |
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Basic information
Public title
Usefullness of thoracic MRI in the management of lung cancer -comparison with FDG-PET-
Acronym
Usefullness of thoracic MRI in the management of lung cancer -comparison with FDG-PET-
Scientific Title
Usefullness of thoracic MRI in the management of lung cancer -comparison with FDG-PET-
Scientific Title:Acronym
Usefullness of thoracic MRI in the management of lung cancer -comparison with FDG-PET-
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical usefullness of thoracic MRI for the diagnosis and evaluation of therapeutic effect in lung cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagonis-diagnostic accuracy based on pathological results.
Evaluation of herapeutic effect-relationship between the degree of response and progression-free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI examination
Interventions/Control_2
FDG-PET
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients suspected of lung cancer on CT examination
Key exclusion criteria
patients with hyperglycemia (over 150mg/dl of fasting blood sugar level)
patients with metalic device in their body
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuro Tsuchida |
Organization
University of Fukui Hospital
Division name
Department of Radiology
Zip code
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-3111
tsucchy@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuro Tsuchida |
Organization
University of Fukui Hospital
Division name
Department of Radiology
Zip code
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-3111
Homepage URL
tsucchy@u-fukui.ac.jp
Sponsor or person
Institute
Department of Radiology, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
None
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
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 05 | Day |
Last modified on
| 2013 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006174
