UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046704 |
|---|---|
| Receipt number | R000053281 |
| Scientific Title | Prospective study on the assessment of diagnostic and therapeutic efficacy of FDG-PET/CT with delayed contrast-enhanced CT on cardiac sarcoidosis |
| Date of disclosure of the study information | 2022/01/25 |
| Last modified on | 2023/01/24 16:06:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the assessment of diagnostic and therapeutic efficacy using contrast-enhanced FDG-PET/CT for cardiac sarcoidosis
Acronym
The assessment of diagnostic efficacy of contrast-enhanced PET/CT for cardiac sarcoidosis
Scientific Title
Prospective study on the assessment of diagnostic and therapeutic efficacy of FDG-PET/CT with delayed contrast-enhanced CT on cardiac sarcoidosis
Scientific Title:Acronym
The assessment of diagnostic efficacy of PET/CT with delayed contrast-enhanced CT for cardiac sarcoidosis
Region
| Japan |
Condition
Condition
Cardiac sarcoidosis
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a new diagnostic protocol for cardiac sarcoidosis and its clinical application in patients with suspected cardiac sarcoidosis by performing a digital PET/CT with iodine contrast material.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance of late iodine enhancement of myocardium using contrast-enhanced PET/CT
Key secondary outcomes
Determination of efficacy after steroid treatment in areas of active inflammation (FDG accumulation) and myocardial fibrosis (delayed enhancement)
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 | Device,equipment |
Interventions/Control_1
Delayed contrast enhanced CT of myocardium
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
(1) Patients for whom written consent has been obtained from the individual
(2) Patients who can be hospitalized and attend outpatient clinics
Key exclusion criteria
1) Patients who have not been fasting for a long time (more than 18 hours)
2) Patients with renal failure(eGFR <30)
3) Patients with hyperthyroidism
4) Patients who are pregnant or of childbearing potential
5) Patients with allergy to contrast material
6) Patients with bronchial asthma
7) Patients who are judged unsuitable for participation in this study by the investigator for other reasons
(8) Patients with poorly controlled diabetes mellitus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kawaguchi |
| Middle name | |
| Last name | Naoto |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
791-0295
Address
Shitsukawa,Toon,Ehime
TEL
089-960-5371
n.kawa1113@gmail.com
Public contact
Name of contact person
| 1st name | Kawaguchi |
| Middle name | |
| Last name | Naoto |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
791-0295
Address
Shitsukawa,Toon,Ehime
TEL
089-960-5371
Homepage URL
n.kawa1113@gmail.com
Sponsor or person
Institute
Ehime university
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa,Toon,Ehime
Tel
089-960-5172
rinri@m.ehime-u.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
| 2022 | Year | 01 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2027 | 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
| 2022 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053281
