UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017057
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email megu@m.kufm.kagoshima-u.ac.jp

Public contact
1st 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
Email megu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima university hospital
Department of Radiology
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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.