UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007179 |
|---|---|
| Receipt number | 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 13:05:14 |
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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
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
kyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine,
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008456
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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