UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050875 |
|---|---|
| Receipt number | R000057961 |
| Scientific Title | Evaluation of metastatic bone lesions by power doppler ultrasonograpgy |
| Date of disclosure of the study information | 2023/04/30 |
| Last modified on | 2024/05/06 10:42:45 |
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Basic information
Public title
Evaluation of metastatic bone lesions by ultrasonograpgy
Acronym
Evaluation of metastatic bone lesions by ultrasonograpgy
Scientific Title
Evaluation of metastatic bone lesions by power doppler ultrasonograpgy
Scientific Title:Acronym
Evaluation of metastatic bone lesions by power doppler ultrasonograpgy
Region
| Japan |
Condition
Condition
metastatic bone tumor from lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of power doppler ultrasonography to the metastatic bone lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of distribution pattern of blood stream signal by power doppler ultrasonography in comparison with that of bone fructure.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The lung cancer patients who show positive bone lesions by bone scintigram.
Those lesions which can be detected and visible by body surface ultrasonography.
Key exclusion criteria
Those who may have intorelable pain induced by the contact with ultrasonography probe.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of Pulmonology
Zip code
1900014
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
TEL
+81425265511
tdmckamimura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of Pulmonology
Zip code
1900014
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
TEL
+81425265511
Homepage URL
tdmckamimura@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
National Hospital Organization Disaster Medical Center
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
Tel
+81425265511
tdmckamimura@yahoo.co.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
| 2023 | Year | 04 | Month | 30 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Twenty nine cases were enrolled by 1st May 2024. Vascular signals were often visible in the cases of metastatic bone tumor. On the other hand, no vascular signals were recognized in the cases of simple bone fructure.
Management information
Registered date
| 2023 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057961
