UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024274
Receipt No. R000027951
Scientific Title Optimization of Ra-223 imaging protocol using gamma cameras for therapeutic and prognostic evaluation in prostate cancer patients metastatic to bone treated with Ra-223 dichloride
Date of disclosure of the study information 2016/10/03
Last modified on 2019/04/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Optimization of Ra-223 imaging protocol using gamma cameras for therapeutic and prognostic evaluation in prostate cancer patients metastatic to bone treated with Ra-223 dichloride
Acronym Optimization of Ra-223 imaging protocol for therapeutic and prognostic evaluation in prostate cancer patients treated with Ra-223
Scientific Title Optimization of Ra-223 imaging protocol using gamma cameras for therapeutic and prognostic evaluation in prostate cancer patients metastatic to bone treated with Ra-223 dichloride
Scientific Title:Acronym Optimization of Ra-223 imaging protocol for therapeutic and prognostic evaluation in prostate cancer patients treated with Ra-223
Region
Japan

Condition
Condition castration-resistant prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to establish the optimal imaging protocol of Ra-223 using gamma cameras in order to quantify Ra-223 uptake in bone metastases and to evaluate the relationship between the quantitative values and therapeutic outcome or prognosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Establishment of the optimal imaging protocol of Ra-223 using gamma cameras in terms of quantitative accuracy and the relationship between the quantitative values of Ra-223 and therapeutic outcome or prognosis
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Prostate cancer patients treated with Ra-223 will receive Ra-223 imaging tests using gamma cameras if written informed consent is obtained.
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 (1) Castration-resistant prostate cancer patients with bone metastasis aged 20 years or over
(2) Patients who were considered eligible for Ra-223 therapy on the basis of the judgment of urologists
(3) Patients who gave written informed consent to this study
Key exclusion criteria (1) Patients who refused to give written informed consent to this study
(2) Patients who are too claustrophobic to lie down on the bed of gamma cameras in spite of the open nature of this imaging device
Target sample size 50

Research contact person
Name of lead principal investigator
1st name TADAKI
Middle name
Last name Nakahara
Organization Keio University School of Medicine
Division name Department of Diagnostic Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email nakahara@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name TADAKI
Middle name
Last name Nakahara
Organization Keio University School of Medicine
Division name Department of Diagnostic Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email nakahara@rad.med.keio.ac.jp

Sponsor
Institute Keio University Hospital
Institute
Department

Funding Source
Organization None
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 Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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
2016 Year 10 Month 03 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
2016 Year 08 Month 29 Day
Date of IRB
2016 Year 10 Month 03 Day
Anticipated trial start date
2016 Year 10 Month 04 Day
Last follow-up date
2022 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
2016 Year 10 Month 03 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027951

Research Plan
Registered date File name
2017/03/15 Ra-223 imaging(研究計画書 ver 1.01).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.