UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026876
Receipt No. R000030780
Scientific Title Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra
Date of disclosure of the study information 2017/04/26
Last modified on 2022/04/11

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Basic information
Public title Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra
Acronym Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra
Scientific Title Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra
Scientific Title:Acronym Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra
Region
Japan

Condition
Condition Castration-resistant prostate cancer with bone metastases
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and to determine a suitable methodology for planar and SPECT imagings with 223Ra.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Planar and SPECT imagings in 223Ra (Xofigo) therapy.
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 Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 SPECT/CT
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Adults
Key exclusion criteria Children
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Katsuhiko
Middle name
Last name Kato
Organization Nagoya University Graduate School of Medicine
Division name Department of Radiological and Medical Laboratory Sciences
Zip code 461-8673
Address 1-20, Daikominami 1-chome, Higashi-ku, Nagoya, Japan
TEL 052-719-1504
Email katokt@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Katsuhiko
Middle name
Last name Kato
Organization Nagoya University Graduate School of Medicine
Division name Department of Radiological and Medical Laboratory Sciences
Zip code 461-8673
Address 1-20, Daikominami 1-chome, Higashi-ku, Nagoya, Japan
TEL 052-719-1504
Homepage URL
Email katokt@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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 Nagoya University Hospital
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel 052-741-2111
Email center@med.nagoya-u.ac.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
2017 Year 04 Month 26 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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 06 Month 15 Day
Anticipated trial start date
2017 Year 06 Month 15 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

Management information
Registered date
2017 Year 04 Month 05 Day
Last modified on
2022 Year 04 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030780

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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