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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021567
Receipt No. R000024867
Scientific Title Diagnostic value of somatostatin receptor scintigraphy on cardiac sarcoidosis
Date of disclosure of the study information 2016/03/22
Last modified on 2019/03/28

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Basic information
Public title Diagnostic value of somatostatin receptor scintigraphy on cardiac sarcoidosis
Acronym Somatostatin receptor scintigraphy and cardiac sarcoidosis
Scientific Title Diagnostic value of somatostatin receptor scintigraphy on cardiac sarcoidosis
Scientific Title:Acronym Somatostatin receptor scintigraphy and cardiac sarcoidosis
Region
Japan

Condition
Condition Cardiac Sarcoidosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Diagnostic value of somatostatin receptor scintigraphy (OctreoScan) on cardiac sarcoidosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection of myocardial involvement and comparison among imaging modalities in patients with cardiac sarcoidosis
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Whole-body and cross sectional images will be obtained using a SPECT camera 4 and 24 hours after injection of 111MBq of OctreoScan
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1 Patients who were diagnosed as Cardiac Sarcoidosis of clinical diagnosis or histological diagnosis.
Key exclusion criteria 1 Patients with a history of adverse
reactions to OctreoScan
2 Patients taking the medication Octreotide
3 Patients having serious liver diseases
4 Patients having chronic renal failure with
a serum creatinine level of 2.0 mg/dL or
higher
5 Patients with malignant neoplasms
6 Pregnant or breastfeeding women
7 Patients having difficulty to get
cooperation
8 Patients who were considered as unsuitable
for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hisao
Middle name
Last name Hara
Organization National Center for Global Health and Medicine
Division name Department of Cardiology
Zip code 1628655
Address 1-21-1Toyama Shinjyuku-ku Tokyo,162-8655, Japan
TEL 03-3202-7181
Email hhara@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Awaya
Organization National Center for Global Health and Medicine
Division name Department of Cardiology
Zip code 1628655
Address 1-21-1Toyama Shinjyuku-ku Tokyo,162-8655, Japan
TEL 03-3202-7181
Homepage URL
Email toru0228@gmail.com

Sponsor
Institute Department of Cardiology, National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
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 National Center for Global Health and Medicine
Address 1-21-1Toyama Shinjyuku-ku Tokyo,162-8655, Japan
Tel 03-3202-7181
Email tawaya@hosp.ncgm.go.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
2016 Year 03 Month 22 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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 20 Day
Date of IRB
2016 Year 02 Month 22 Day
Anticipated trial start date
2016 Year 03 Month 23 Day
Last follow-up date
2018 Year 08 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
2016 Year 03 Month 22 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024867

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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