UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016018 |
|---|---|
| Receipt number | R000018603 |
| Scientific Title | Clinical value of image fusion from MR and MR-compatible flexible PET |
| Date of disclosure of the study information | 2014/12/22 |
| Last modified on | 2015/06/23 13:40:11 |
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Basic information
Public title
Clinical value of image fusion from MR and MR-compatible flexible PET
Acronym
Clinical value of image fusion from MR and MR-compatible flexible PET
Scientific Title
Clinical value of image fusion from MR and MR-compatible flexible PET
Scientific Title:Acronym
Clinical value of image fusion from MR and MR-compatible flexible PET
Region
| Japan |
Condition
Condition
Malignant tumors except for early gastric cancer.
Cardiac sarcoidosis.
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Cardiology |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Radiology |
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical value of image fusion from MR and MR-compatible flexible PET.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
quality of the flexible PET image, efficacy of the semiquantitative analysis by the flexible PET device, accuracy of image fusion from MR and MR-compatible flexible PET
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
| Device,equipment |
Interventions/Control_1
Patients, who are suspected malignancy, undergo not only the conventional PET-CT scan, but also the additional scan by the flexible PET and MRI.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who are going to undergo the PET/CT with applied health insurance and agree to sign the written consent form of the study
2)Patients who are over 20 years of age and more when they are registered in the study
Key exclusion criteria
1)Patients who disagree to take part in the study
2)Patients who are under 20 years old
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Togashi Kaori |
Organization
Kyoto University
Division name
Department of Diagnostic Imaging and Nuclear Medicine Graduate School of Medicine
Zip code
Address
4, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city
TEL
075-751-3760
ktogashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryusuke Nakamoto |
Organization
Kyoto University
Division name
Department of Diagnostic Imaging and Nuclear Medicine Graduate School of Medicine
Zip code
Address
4, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city
TEL
075-751-3760
Homepage URL
inabook@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shimadzu Corporation
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 | 12 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | 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 | 12 | Month | 21 | Day |
Last modified on
| 2015 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018603
