UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024788 |
|---|---|
| Receipt number | R000028503 |
| Scientific Title | Study for early PET/MR imaging after intravenous administration of FDG in malignant and inflammatory diseases |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2016/11/10 13:48:20 |
* 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
Study for early PET/MR imaging after intravenous administration of FDG in malignant and inflammatory diseases
Acronym
Kyushu University PET/MR imaging
Scientific Title
Study for early PET/MR imaging after intravenous administration of FDG in malignant and inflammatory diseases
Scientific Title:Acronym
Kyushu University PET/MR imaging
Region
| Japan |
Condition
Condition
Malignant and inflammatory diseases
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the usefulness of early FDG-PET/MR imaging in the detection, characterization, tumor staging and determination of treatment response of malignant lesions and in the differentiation of malignant from inflammatory lesions, and also to compare diagnostic performance of FDG-PET/MR imaging with that of other imaging modalities such as CT, MRI and FDG-PET/CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Diagnostic performance including the detection, characterization, tumor staging, determination of treatment response of malignant lesions, and the differentiation of malignant from inflammatory lesions
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
| Other |
Interventions/Control_1
PET/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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Malignant and/or inflammatory disease in head/neck, chest, abdomen/pelvis, and muscloskeltal regions
Key exclusion criteria
Contraindication of MRI
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Watanabe |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Molecular Imaging and Diagnosis
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425695
yw140557@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryotaro Kamei |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Clinical Radiology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425695
Homepage URL
rkamei@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Graduate School of Medical Sciences
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
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
| 2016 | Year | 11 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | 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
| 2016 | Year | 11 | Month | 10 | Day |
Last modified on
| 2016 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028503
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
