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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007179
Receipt No. R000008456
Scientific Title Effects and Safety of Repeated 131I metaiodophenylguanitidine (MIBG) in Patients with Malignant Pheochromocytoma and Paraganglioma
Date of disclosure of the study information 2012/02/10
Last modified on 2018/09/17

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Basic information
Public title Effects and Safety of Repeated 131I metaiodophenylguanitidine (MIBG) in Patients with Malignant Pheochromocytoma and Paraganglioma
Acronym RIMAP Study
Scientific Title Effects and Safety of Repeated 131I metaiodophenylguanitidine (MIBG) in Patients with Malignant Pheochromocytoma and Paraganglioma
Scientific Title:Acronym RIMAP Study
Region
Japan

Condition
Condition Malignant Pheochromocytoma and Malignant Paraganglioma
Classification by specialty
Endocrinology and Metabolism Hematology and clinical oncology Surgery in general
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. The primary purpose of this study was to investigate the effects and safety of repeated MIBG radiotherapy in patients with metastatic pheocchromocytoma and paraganglioma.
2. The secondary purpose of this study is to evaluate a utility of 18F FDG PET in the prediction of progressive lesions in patients with malignant pheochromocytoma and paraganglioma.
3. The third purpose of this study is to predict disease progression in lesions with I-131 MIBG negative but 18F FDG PET positive lesions in patients with malignant pheochromocytoma and paraganglioma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We will evaluate therapeutic response using blood work, urine correction, clinical symptoms, whole-body CT, F-18 FDG PET/CT, and I-131 MIBG before and after I-131 MIBG radiotherapy.
We will also evaluate the adverse effects using blood work, symptoms, and other imaging studies.
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 No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients with malignant pheochromocytoma and paraganglioma will have 100 to 150 mCi of 131I MIBG radiotherapy10. These patients will have repeated 131I MIBG radiotherapy within 6 months after the initial treatment and will have 3 treatment sessions.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with malignant pheochromocytoma and paraganglioma who will undergo I-131 MIBG therapy and have follow-up imaging studies.
Key exclusion criteria life expectancy less than 3 month due to other co-morbidity
very low ADL ability
age < 18 years, pregnant or breast-feeding
inability to obtain informed consent
claustrophobia
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichiro Yoshinaga, M.D., Ph.D, F.A.C.C..
Organization Hokkaido University Graduate School of Medicine,
Division name Department of Molecular Imaging
Zip code
Address Kita-15, Nishi-7, Kita-Ku, Sapporo,
TEL 011-706-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiichiro Yoshinaga, M.D., Ph.D, F.A.C.C..
Organization Hokkaido University Graduate School of Medicine,
Division name Department of Molecular Imaging
Zip code
Address Kita-15, Nishi-7, Kita-Ku, Sapporo,
TEL 011-706-5151
Homepage URL
Email kyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine,
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization
Nationality of Funding Organization none

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2012 Year 02 Month 10 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 No longer recruiting
Date of protocol fixation
2000 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2000 Year 10 Month 01 Day
Last follow-up date
2015 Year 09 Month 01 Day
Date of closure to data entry
2015 Year 12 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 31 Day
Last modified on
2018 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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