UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047844 |
|---|---|
| Receipt number | R000054546 |
| Scientific Title | Utility of dual energy CT for metastatic bone tumor detection |
| Date of disclosure of the study information | 2022/05/25 |
| Last modified on | 2023/07/02 11:02:00 |
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Basic information
Public title
Utility of dual energy CT for metastatic bone tumor detection
Acronym
Value of DECT for bone metastasis detection
Scientific Title
Utility of dual energy CT for metastatic bone tumor detection
Scientific Title:Acronym
Value of DECT for bone metastasis detection
Region
| Japan |
Condition
Condition
metastatic bone tumor
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Computed tomography(CT) is well recognized tool for screening
metastatic lesion in cancer patients. However, when it comes to
metastatic bone tumors(MBT),CT has the lowest sensitivity for detection compared with MRI, PET, and bone scintigraphy. Virtual non-calcium image(VNCa) which can be made by scanning with dual-energy CT has potential to improve detectability of bone marrow abnormalities.
Recently, VNCa showed better detectability rate of multiple myeloma on
VNCa than on standard CT image. Hence, in this study we attempt to see
if the detectability of MBT on CT improve with creating VNCa. MRl is
going to be used as a gold standard image.
Basic objectives2
Others
Basic objectives -Others
evaluate the difference of CT number between MBT and normal bone marrow on VNCa
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
See if there is a significant difference in diagnostic performance for MBT detection between conventional CT (CCT) image only and CCT with VNCa by visual analysis. MRI is used as a reference.
Key secondary outcomes
Measure and see the difference in CT number between normal marrow and MBT on VNCa.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with MBT in the spine
Key exclusion criteria
too poor performance status to
participate this study
patients who needs emergent surgery
patients who have contraindication for MRI
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Fukuda |
Organization
The Jikei University School of Medicine
Division name
Department of Radiology
Zip code
105-8471
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
TEL
0334331111
takeshifukuda@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Fukuda |
Organization
The Jikei University School of Medicine
Division name
Department of Radiology
Zip code
105-8471
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
TEL
0334331111
Homepage URL
takeshifukuda@jikei.ac.jp
Sponsor or person
Institute
The Jikei University Schoolo of Medicine
Institute
Department
Personal name
Funding Source
Organization
GE healthcare pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
Tel
0336331111
rinri@jikei.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 | 05 | 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 | 03 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
compare the diagnostic performance for MBT between CCT and CCT with VNCa
Management information
Registered date
| 2022 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054546
