UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030642 |
|---|---|
| Receipt number | R000034988 |
| Scientific Title | Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis for cardiac sarcoidosis |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2019/03/29 16:52:27 |
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Basic information
Public title
Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis for cardiac sarcoidosis
Acronym
Clinical study of diagnosis for cardiac sarcoidosis
Scientific Title
Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis for cardiac sarcoidosis
Scientific Title:Acronym
Clinical study of diagnosis for cardiac sarcoidosis
Region
| Japan |
Condition
Condition
Cardiac sarcoidosis
Classification by specialty
| Medicine in general | Cardiology | Clinical immunology |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of 4DST-PET for diagnosis of cardiac sarcoidosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To explore how 4DST-PET can contribute to diagnosis of cardiac sarcoidosis, compared to FDG-PET.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
The patients undergo both 4DST- and FDG-PET studies. The findings will be compared reciprocally. In the procedure, clinical findings according to the guideline of management of cardiac sarcoidosis published from the Japanese circulation society is referred.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient who is suspected cardiac sarcoidosis
2) Age, elder than or equal to 20 years.
3) Completed the written informed consent.
Key exclusion criteria
1) Patient who is in emargency status
2) Patient with severe comorbid disease including liver dysfunction, renal dysfunction or metabolic damage.
3) Patient with severe mental disease.
4) Patient who have possibility of pregnant, during lactation
5) Patient who have history of allergy to thyothyidine and thymidine
6) Those who are determined as not appropriate for the study by the principal investigator.
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Nuclear Medicine
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
rminamimoto@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Nuclear Medicine
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
rminamimoto@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034988
