UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016327 |
|---|---|
| Receipt number | R000017852 |
| Scientific Title | Utility of syngo iFlow in the assessment of Bladder Cancer Treatment |
| Date of disclosure of the study information | 2015/01/28 |
| Last modified on | 2016/01/26 21:16:37 |
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Basic information
Public title
Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Acronym
Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Scientific Title
Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Scientific Title:Acronym
Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Region
| Japan |
Condition
Condition
Bladder Cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Advanced bladder carcinoma is commonly treated by radical cystectomy. However, at Osaka Medical College (OMC), balloon occluded arterial infusion (BOAI) combined with hemodialysis and radiation therapy (OMC regimen) has been performed, and this method has shown good response rates. Here, we present the analysis of the hemodynamics on BOAI by using the software, syngo iFlow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For 30 cases, in BOAI and non-BOAI patterns we analysed the flow of contrast material in the bladder artery, superior gluteal artery, and inferior gluteal artery by using the software, syngo iFlow.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Newly developed bladder preservation therapy for bladder cancer using double balloon-occluded-arterial-infusion (BOAI) of an anticancer agent known as OMC (Osaka Medical College) regimen has allowed 83% of the patients to achieve complete response. This study aims to elucidate the quantitative difference in hemodynamics of the bladder arteries between double balloon occluded catheter (D-BOC) and conventional single balloon occluded catheter (S-BOC) in which only proximal balloon is inflated by using syngo iFlow (Siemens Healthcare).
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
Invasive bladder cancer patients aged 20 years or older
Key exclusion criteria
The cases that the catheter could not be placed in the right position.
The patients having iodine hypersensitivity.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Narumi |
Organization
Osaka Medical College
Division name
Department of Radiology
Zip code
Address
2-7, Daigakumachi, Takatsuki-City, Osaka
TEL
072-683-1221
narumi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyohito Yamamoto |
Organization
Osaka Medical College
Division name
Department of Radiology
Zip code
Address
2-7, Daigakumachi, Takatsuki-City, Osaka
TEL
072-683-1221
Homepage URL
rad105@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Siemens Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 01 | Month | 28 | 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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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
| 2015 | Year | 01 | Month | 25 | Day |
Last modified on
| 2016 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017852
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
