UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017057 |
|---|---|
| Receipt number | R000019775 |
| Scientific Title | I-131 MIBG(I-131 Meta-Iodobenzylguanidine) radiotherapy for malignant neuroendocrine tumors |
| Date of disclosure of the study information | 2015/04/14 |
| Last modified on | 2017/10/11 14:54:32 |
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Basic information
Public title
I-131 MIBG(I-131 Meta-Iodobenzylguanidine) radiotherapy for malignant neuroendocrine tumors
Acronym
I-131 MIBG radiotherapy for malignant neuroendocrine tumors
Scientific Title
I-131 MIBG(I-131 Meta-Iodobenzylguanidine) radiotherapy for malignant neuroendocrine tumors
Scientific Title:Acronym
I-131 MIBG radiotherapy for malignant neuroendocrine tumors
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 toxity of I-131 MIBG therapy for malignant neuroedocrine tumors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Therapeutic effect and side effects
Key secondary outcomes
The difference of uptake degree between local intraarterial injection by the reservoir and intravenous injection
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
I-131 MIBG therapy
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
Patients with unresectable I-131 positive malignant neuroendocrine tumors and with written informed consent for I-131 MIBG therapy
Patients with ability for treatment in an isolation room
Key exclusion criteria
Under pregnant or breast feeding
Life expectancy less than 1 month
Renal disorder (GFR<30ml/min)
Limited bone marrow capacity (WBC<3000,platelet<100,000)
Understanding and cooperation cannnot be obtained from family members
When medical staff determine that treatment cannot be properly carried out.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Megumi Jinguji |
Organization
Kagoshima university hospital
Division name
Raiology
Zip code
Address
8-35-1 Sakuragaoka, Kagohima 890-8544, Japan
TEL
099-275-5417
megu@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Jinguji |
Organization
Kagoshima university hospital
Division name
Raiology
Zip code
Address
8-35-1 Sakuragaoka, Kagohima 890-8544, Japan
TEL
099-275-5417
Homepage URL
megu@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima university hospital
Department of Radiology
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 14 | 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
| 2015 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 06 | Day |
Last modified on
| 2017 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019775
