UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031988 |
|---|---|
| Receipt number | R000036514 |
| Scientific Title | Assessment of cardiac sarcoidosis by using PET tracer 18F-FMISO that accumulates in hypoxic tissues |
| Date of disclosure of the study information | 2018/03/30 |
| Last modified on | 2019/03/30 20:19:51 |
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Basic information
Public title
Assessment of cardiac sarcoidosis by using PET tracer 18F-FMISO that accumulates in hypoxic tissues
Acronym
Assessment of cardiac sarcoidosis by using 18F-FMISO
Scientific Title
Assessment of cardiac sarcoidosis by using PET tracer 18F-FMISO that accumulates in hypoxic tissues
Scientific Title:Acronym
Assessment of cardiac sarcoidosis by using 18F-FMISO
Region
| Japan |
Condition
Condition
cardiac sarcoidosis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the FMISO uptake to cardiac sarcoidosis lesions and to compare the FMISO uptake to FDG uptake. The aim of this study was to research the potential of FMISO PET to detect CS precisely.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of FMISO uptake to cardiac sarcoidosis leisons.
Key secondary outcomes
Sensitivity and specificity for diagnose cardiac sarcoidosis. A correlation coefficient between FMISO uptake and FDG uptake.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
We intervene in patients for suspected or diagnosed cardiac sarcoidosis. FDG PET and FMISO PET are performed and we investigate the results. FMISO PET is performed before and during steroid therapy.FDG and FMISO studies are performed on different days. FMISO PET is performed around the same time of FDG PET.
FMISO PET scans are acquired after administration of FMISO. FMISO scanning is acquired 1,2,4 hours after the administration.FMISO scanning will be conducted 1,2,4 hours after the administration of 4.5 MBq/kg of FMISO to allow for tracer equilibrium. This study is scheduled from April 1,2018 to December 31,2020.
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
Patients for suspected or diagnosed cardiac sarcoidosis. Patients who met the diagnostic criteria of cardiac sarcoidosis.
Key exclusion criteria
Steroid therapy was initiated prior to the first scan.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Shiga |
Organization
Hokkaido University
Division name
Department of nuclear medicine
Zip code
0608638
Address
Sapporo city Kita14 Nishi 5 chome
TEL
011-706-5152
s42090092o@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Furuya |
Organization
Hokkaido University
Division name
Department of nuclear medicine
Zip code
0608638
Address
Sapporo city Kita14 Nishi 5 chome
TEL
011-706-5152
Homepage URL
s42090092o@gmail.com
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Hokkaido University Hospital
Address
Sapporo City Kita 14 Nishi 5
Tel
011-701-7636
crjimu@huhp.hokudai.ac.jp
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 | 03 | Month | 30 | 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
11
Results
Eleven patients suspected or diagnosed as CS have been enrolled in this study since April 2018. All patients underwent FMISO PET and FDG-PET within 10 days.
Nine patients were diagnosed as CS with a focal myocardial FDG uptake. Of these 9 patients, 7 patients showed focal FMISO uptake consistent with FDG uptake and 2 patients did not show FMISO uptake.
For the remaining two patients who were not diagnosed as CS showed no significant FMISO accumulation in the myocardium.
Results date posted
| 2019 | Year | 03 | Month | 30 | Day |
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
| 2018 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | 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
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036514
