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

Email

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


Email

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


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

Value
https://center6.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