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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002836
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003460

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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