UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013714 |
|---|---|
| Receipt number | R000016012 |
| Scientific Title | Safety test of inserting small gold fiducials for prostate cancer |
| Date of disclosure of the study information | 2014/04/15 |
| Last modified on | 2020/04/23 21:41:35 |
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Basic information
Public title
Safety test of inserting small gold fiducials for prostate cancer
Acronym
Safety test of inserting small gold fiducials for prostate cancer
Scientific Title
Safety test of inserting small gold fiducials for prostate cancer
Scientific Title:Acronym
Safety test of inserting small gold fiducials for prostate cancer
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of radiotherapy for prostate cancer using Au fiducials with 1.5mm diameter
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence of the Au marker invisibility for the usage of patient localization before and during radiotherapy
Key secondary outcomes
Incidence of the Au marker migration at one month after completion of the radiotherapy
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Au marker in 1.5mm diameter
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) Age 20-yrs old or over at the time of consent form is obtained.
2) PS is 0-3 in the criteria of ECOG.
3) Patients who are considered to be capable for insertion of Au marker (2.0mm in diameter) to the prostate gland for radiotherapy.
4) Explained well and consent to this study.
Key exclusion criteria
1) previous history of partial or total resection of prostate gland or bladder
2) the proposed radiation treatment site had been given tolerance dose in the past
3) cannot be held rest for about 30 minutes
4) weight over 135kg
5) with serious active infections in the irradiated sites
6) with severe diabetes that uncontrolled, or treated by using insulin
7) with pulmonary arteriovenous fistula, atrial heart septal defect, ventricular heart septal defect or other shunt between right and left heart
8) severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia
9) with the state of DIC, bleeding tendency, who cannot halt the anticoagulant therapy even the temporary.
10) considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
11) allergic to au materials.
12) unsuitable for enrollment judged by principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Shimizu |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
060-8638
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido
TEL
+81-11-706-5977
sshing@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Shimizu |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
060-8638
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido
TEL
+81-11-706-5977
Homepage URL
sshing@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2014 | Year | 04 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2019 | 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
| 2014 | Year | 04 | Month | 14 | Day |
Last modified on
| 2020 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016012
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| Registered date | File name |
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