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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002530
Receipt No. R000003090
Scientific Title Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG)
Date of disclosure of the study information 2009/09/18
Last modified on 2019/05/20

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Basic information
Public title Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG)
Acronym Targeted radiotherapy for chemotherapy resistant neuroblastoma with MIBG
Scientific Title Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG)
Scientific Title:Acronym Targeted radiotherapy for chemotherapy resistant neuroblastoma with MIBG
Region
Japan

Condition
Condition neuroblastoma
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe therapeutic efficacy and toxicity of standard dose and high dose MIBG therapy in chemotherapy resistant neuroblasttoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)assessment of anti-tumor effects with tumor size and tumor markers
2)assessment of prognosis
3)assessment of symptoms
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
Interventions/Control_1 targeted radiotherapy
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
1 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)patients with histologically proven neuroblastoma
2)positive I131-MIBg uptake
3)patients with written informed consent from parents
4)patients with ADL adequate for treatment in an isolation room. patients with limited ADL which can be compensated by the others under the approval of the ethical board
5)in case that high-dose treatment is chosen, bone marrow support must be secured.
Key exclusion criteria 1)patients with disturbed consciousness
2)expected life span less than 1 month
3)limited bone marrow capacity
Hb<9.0, WBC count<3,000, platelet count <100,000
4)renal disorder
GFR<30 ml/min/1.73 m2
5)risks for the central nerve system during treatment
6)in case that radiation safety cannot be secured. in case with uncontrolled symptoms that may require emergent medical cares. in case that understanding and cooperation cannot be obtained from family members.
7) when medical staff determine that treatment cannot be properly carried out.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Seigo
Middle name
Last name Kinuya
Organization Kanazawa university Hospital
Division name Department of Nuclear Medicine
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa, Ishikawa
TEL 076-265-2333
Email kinuya@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Seigo
Middle name
Last name Kinuya
Organization Kanazawa University Hospital
Division name Department of Nuclear Medicine
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa, Ishikawa
TEL 076-265-2333
Homepage URL
Email kinuya@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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 Innovative Clinical Research Center, Kanazawa University
Address 13-1, Takara-machi, Kanazawa
Tel 076-265-2090
Email crc.irb-knz@esct.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
2009 Year 09 Month 18 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 09 Month 10 Day
Date of IRB
2009 Year 09 Month 11 Day
Anticipated trial start date
2009 Year 09 Month 11 Day
Last follow-up date
2020 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
2009 Year 09 Month 18 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003090

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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