UMIN-CTR Clinical Trial

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

cardiac sarcoidosis

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hokkaido University Hospital

Address

Sapporo City Kita 14 Nishi 5

Tel

011-701-7636

Email

crjimu@huhp.hokudai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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