UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014499 |
|---|---|
| Receipt number | R000016866 |
| Scientific Title | Radioisotope uptake in hybrid PET/MR system:comparison with PET/CT |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2017/01/08 15:49:09 |
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Basic information
Public title
Radioisotope uptake in hybrid PET/MR system:comparison with PET/CT
Acronym
Radioisotope uptake in PET/MR
Scientific Title
Radioisotope uptake in hybrid PET/MR system:comparison with PET/CT
Scientific Title:Acronym
Radioisotope uptake in PET/MR
Region
| Japan |
Condition
Condition
Malignancies
Epilepsy
Cardial fairue, Cardiac Salcoidosis
Classification by specialty
| Medicine in general | Cardiology | Hematology and clinical oncology |
| Surgery in general | Neurosurgery | Adult |
| Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the quantitative performance of PET/MR for radioisotope uptake in lesions or normal tissues by comparing with that of PET/CT.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Standardized uptake value (SUV) of radioisotope in lesions and normal tissues
Key secondary outcomes
Histological grades and stage of malignant tumors
Myocardial viability and diagnostic performance for cardiac sarcoidosis.
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
| Device,equipment |
Interventions/Control_1
Hybrid PET/MR system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who undergo PET/CT for clinical purpose
2. Inclusion: malignancies (except for early gastric cancer), intractable partial epilepsy, Cardiac failure or Cardiac sarcoidosis
3. no limit for age, both males and females
4. Written informed consent is obtained by adults patients
5. Written informed consent is obtained by guardians of pediatric patients
Key exclusion criteria
1. contraindication of PET
pregnant
claustrophobia
2. contraindication of MR
cardiac pacemaker
cochlear implant
artificial heart valve
history of surgery for cerebral aneurisms
dentures
tattoo
metallic foreign body
claustrophobia
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Honda |
Organization
Graduate School of Medical Sciences
Division name
Department of Clinical Radiology
Zip code
Address
3-1-1 Maidashi Higashiku Fukuoka Japan
TEL
092-642-5695
honda@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Togao |
Organization
Graduate School of Medical Sciences
Division name
Department of Clinical Radiology
Zip code
Address
3-1-1 Maidashi Higashiku Fukuoka Japan
TEL
092-642-5695
Homepage URL
togao@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Radiology, Graduate School of Medical Sciences, Kyushu 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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 07 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 07 | Day |
Last modified on
| 2017 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016866
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
