UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021567
Receipt number 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 2020/10/06 18:42:37

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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 or person

Institute

Department of Cardiology, 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

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

http://jssog.com/papers/2019_0102_10.pdf

Publication of results

Published


Result

URL related to results and publications

http://jssog.com/papers/2019_0102_10.pdf

Number of participants that the trial has enrolled

4

Results

SSTR scintigram-positive region was observed in 3 of the 4 patients. SSTR scintigram-positive regions were observed in 11 of 20 abnormal regions of CMR images (late gadolinium enhancement (LGE) or high signal in T2 weighted black blood (BB) images).

Results date posted

2020 Year 03 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 11 Month 14 Day

Baseline Characteristics

4 patients who were diagnosed with cardiac sarcoidosis (CS) clinically or histologically

Participant flow

SSTR scintigraphy, CMR imaging, 18F-FDG PET (pretest preparation of a 24h-fast and the last meal of low carbohydrates) and TTE were compared.

Adverse events

nothing

Outcome measures

identification of lesion and comparison with existing imaging tests.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

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

2020 Year 10 Month 06 Day



Link to view the page

Value
https://center6.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