UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024274
Receipt number 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 2020/10/06 11:06:27

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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 or person

Institute

Keio University Hospital

Institute

Department

Personal name



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

Completed

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

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 03 Day

Last modified on

2020 Year 10 Month 06 Day



Link to view the page

Value
https://center6.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