UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004267 |
|---|---|
| Receipt number | R000005094 |
| Scientific Title | PET/CT finding of cardiac sarcoidosis |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2010/09/27 12:15:40 |
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Basic information
Public title
PET/CT finding of cardiac sarcoidosis
Acronym
PET/CT finding of cardiac sarcoidosis
Scientific Title
PET/CT finding of cardiac sarcoidosis
Scientific Title:Acronym
PET/CT finding of cardiac sarcoidosis
Region
| Japan |
Condition
Condition
sarcoidosis
Classification by specialty
| Cardiology | Pneumology | Clinical immunology |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
examine useful that uptake on 18F-FDG PET/CT images before giving heparinNa indicates cardiac involvement of sarcoidosis.
Basic objectives2
Others
Basic objectives -Others
diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
uptake on 18F-FDG PET/CT for cardiac muscle
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Give heparin Na before 18F-FDG PET/CT in the diagnosis of cardial sarcoidosis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with histopathological and/or clinical diagnosis of sarcoidosis.
2. Informed consent
Key exclusion criteria
1.Serious concomitant medical illness
2.Obvious bleeding tendency
3.Patients with gastrointestinal ulcer
4.Patients with heparin Na allegy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Ootsuka |
Organization
Tokushima University Hospital
Division name
Radiology
Zip code
Address
2-50-1 Kuramoto-tyou Tokushima-shi Tokushima-ken
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima University Hospital
Division name
the general affairs section
Zip code
Address
TEL
088-631-3111
Homepage URL
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2010 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 09 | Month | 27 | Day |
Last modified on
| 2010 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005094
