UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002836 |
|---|---|
| Receipt number | R000003460 |
| Scientific Title | Development of new positioning system in stereotactic irradiation for the brain tumor by linac-mounted cone-beam CT with contrast media administration |
| Date of disclosure of the study information | 2009/12/04 |
| Last modified on | 2010/12/03 14:10:34 |
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Basic information
Public title
Development of new positioning system in stereotactic irradiation for the brain tumor by linac-mounted cone-beam CT with contrast media administration
Acronym
Development of new positioning system in stereotactic irradiation for the brain tumor by linac-mounted cone-beam CT with contrast media administration
Scientific Title
Development of new positioning system in stereotactic irradiation for the brain tumor by linac-mounted cone-beam CT with contrast media administration
Scientific Title:Acronym
Development of new positioning system in stereotactic irradiation for the brain tumor by linac-mounted cone-beam CT with contrast media administration
Region
| Japan |
Condition
Condition
metastatic brain tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop the new non-invasive positioning system in stereotactic irradiation for brain tumor by linac-mounted cone-beam CT with contrast media administration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Setup error at the positioning
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
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
The patient is setup by registration of kilovoltage cone-beam CT under contrast media administration to the planning 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Metastatic brain tumors with maximum size of < 3 cm and less than 3 lesions
Histopathological confirmation of malignancy in the primary site
No history of intracranial irradiation
Tumors enhanced by contrast media administration
Laboratory tests within 28 days before accrual
1. WBC >= 4,000/mm3 and < 12,000/mm3
2. Neutrophil >= 2,000/mm3
3. Platelet >= 50,000/mm3
4. Hb >= 8.0 g/dl
5. Cre <= 1.1 mg/dl
6. expected Ccr >= 50ml/min (Cockcroft-Gault)
PS 0-2, or PS3 due to the neurologic symptoms by brain tumor
Age >= 20
Written informed consent
Key exclusion criteria
Active multiple cancer
Women with pregnancy or with intent or possibility of pregnancy
Chemotherapeutic agent (excluding hormone therapy) administered within 14 days
Chronic renal failure requiring medical intervention
Difficulty in application of head fixation shell
History of an allergic reaction to iodine contrast media
History of asthma
Other conditions inappropriate for accrual
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Igaki |
Organization
Teikyo University School of Medicine
Division name
Department of Radiology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Igaki |
Organization
Teikyo University Hospital
Division name
Department of Radiology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teikyo University School of Medicine
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
Address
Tel
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
帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 04 | 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
| 2009 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 03 | Day |
Last modified on
| 2010 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003460
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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