UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	I-131 MIBG(I-131 Meta-Iodobenzylguanidine) radiotherapy for malignant neuroendocrine tumors
Title of the study (Brief title)	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	Megumi Jinguji
Organization	Kagoshima university hospital
Division name	Raiology
Address	8-35-1 Sakuragaoka, Kagohima 890-8544, Japan
TEL	099-275-5417
Email	megu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Megumi Jinguji
Organization	Kagoshima university hospital
Division name	Raiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 04 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019775