UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019222 |
|---|---|
| Receipt number | R000022215 |
| Scientific Title | Comparison of MRI pulse sequences in defining outline of prostate and gold fiducial marker for CT/MRI fusion of IMRT for prostate cancer |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2018/04/24 11:10:25 |
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Basic information
Public title
Comparison of MRI pulse sequences in defining outline of prostate and gold fiducial marker for CT/MRI fusion of IMRT for prostate cancer
Acronym
Comparisopn of MRI pulse sequences for ideal prostate IMRT
Scientific Title
Comparison of MRI pulse sequences in defining outline of prostate and gold fiducial marker for CT/MRI fusion of IMRT for prostate cancer
Scientific Title:Acronym
Comparisopn of MRI pulse sequences for ideal prostate IMRT
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find an ideal MRI sequences comparing T1-weighted image, T2-weighted image, T2*3D-weighted and contrast enhanced T1-weighted image. It includes the outline of prostate and gold fiducial marker in prostate. Blinded 2 observers score the quality of images individually.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Finding of an ideal MRI sequences from scoring T1-weighted image, T2-weighted image, T2*3D-weighted and contrast enhanced T1-weighted image by blinded 2 observers.
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Magnetic resonance imaging
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
| 50 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
The eligibility of this study is given by informed consent to enroll this study.
Key exclusion criteria
No available
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Tanaka |
Organization
Gifu Municipal Hospital
Division name
Radiation Oncology
Zip code
Address
7-1 Kashima-cho Gifu
TEL
81-58-251-1101
osa0508@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Tanaka |
Organization
Gifu Municipal Hospital
Division name
Radiation Oncology
Zip code
Address
7-1 Kashima-cho Gifu
TEL
81-58-251-1101
Homepage URL
osa0508@yahoo.co.jp
Sponsor or person
Institute
Gifu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
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
岐阜市民病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study.
The patients are treated in our hospital.
Observing time is between 2015 October to 2016 March.The patients give their written informed consent.
Management information
Registered date
| 2015 | Year | 10 | Month | 03 | Day |
Last modified on
| 2018 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022215
