UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002529 |
|---|---|
| Receipt number | R000003089 |
| Scientific Title | Targeted radiotherapy for malignant neuroendocrine tumors with I-131 metaiodobenzylguanidine (MIBG) |
| Date of disclosure of the study information | 2009/09/18 |
| Last modified on | 2019/05/20 14:57:13 |
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Basic information
Public title
Targeted radiotherapy for malignant neuroendocrine tumors with I-131 metaiodobenzylguanidine (MIBG)
Acronym
Targeted radiotherapy for malignant neuroendocrine tumors with MIBG
Scientific Title
Targeted radiotherapy for malignant neuroendocrine tumors with I-131 metaiodobenzylguanidine (MIBG)
Scientific Title:Acronym
Targeted radiotherapy for malignant neuroendocrine tumors with MIBG
Region
| Japan |
Condition
Condition
malignant neuroendocrine tumors
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 malignant neuroendocrine tumors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patients with histologically proven malignant neuroendocrine tumors
2)patients with metastases, recurrent lesions or unresectable lesions
3)positive I131-MIBg uptake
4)patients with written informed consent
5)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.
Key exclusion criteria
1)pregnant female and feeding female
2)patients with disturbed consciousness
3)expected life interval less than 1 month
4)limited bone marrow capacity
Hb<9.0, WBC count<3,000, platelet count <100,000
5)renal disorder
GFR<30 ml/min/1.73 m2
6)risks for the central nerve system during treatment
7)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.
8) when medical staff determine that treatment cannot be properly carried out.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Kinuya |
Organization
Kanzawa University Hospital
Division name
Department of Nuclear Medicine
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
076-265-2333
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, Takara-machi, Kanazawa
TEL
076-265-2333
Homepage URL
kinuya@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
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
Innovative Clinical Research Center, Kanazawa University
Address
13-1, Takara-machi, Kanazawa
Tel
076-265-2090
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003089
