UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013377 |
|---|---|
| Receipt number | R000015603 |
| Scientific Title | Diagnosis of prostate cancer using carbon-11 labeled choline PET/CT |
| Date of disclosure of the study information | 2014/03/13 |
| Last modified on | 2016/09/11 15:20:58 |
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Basic information
Public title
Diagnosis of prostate cancer using carbon-11 labeled choline PET/CT
Acronym
Choline PET/CT for prostate cancer
Scientific Title
Diagnosis of prostate cancer using carbon-11 labeled choline PET/CT
Scientific Title:Acronym
Choline PET/CT for prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To improve the diagnostic accuracy for the metastasis of high-risk prostate cancer, and for the detection of recurrent foci in the PSA recurrence after therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive predictive value
Key secondary outcomes
Additional information with 11C-choline PET/CT.
Sensitivity.
Clinical impact.
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
| Medicine |
Interventions/Control_1
PET/CT imaging will be performed 5 min after injection of 11C-Choline. Images will be evaluated for the detection of lymphnode/bone metastasis.
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
Key inclusion criteria
Patients of high risk group of prostate cancer: PSA level over 20ng/mL, Gleason score over 8.
Patients suspected of recurrence of prostate cancer after therapy: Re-elevation of PSA level.
Key exclusion criteria
Those who have not signed the informed consent form.
Those who are severe systemic condition with serious underlying disease.
Those who have been decided not appropriate for enrollment by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Minowada |
Organization
National Center for Global Health and Medicine
Division name
Department of Urology
Zip code
Address
1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL
03-3202-7181
sminowad@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Kubota, Yoko Miyata, Momoko Okasaki |
Organization
National Center for Global Health and Medicine
Division name
Div.Nuclear Medicine, Dept.Radiology
Zip code
Address
1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL
03-3202-7181
Homepage URL
rikensa@lily.ocn.ne.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine, Department of Urology
Organization
Division
Category of Funding Organization
Other
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
国立国際医療研究センター病院
National Center for Global Health and Medicine
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 13 | 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 | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
| 2014 | Year | 03 | Month | 09 | Day |
Last modified on
| 2016 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015603
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| Registered date | File name |
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| Registered date | File name |
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