UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013377
Receipt No. 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

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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
Email 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
Email rikensa@lily.ocn.ne.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015603

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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