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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031988
Receipt No. 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

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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
Email 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
Email s42090092o@gmail.com

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036514

Research Plan
Registered date File name
2019/03/30 [No.017-0232]_同意説明文書_第1.8版【180918承認】.docx

Research case data specifications
Registered date File name
2019/03/30 [No.017-0232]_研究実施計画書_第1.6版【180918承認】.doc

Research case data
Registered date File name


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