UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015606 |
|---|---|
| Receipt number | R000018133 |
| Scientific Title | Study for usefulness of iodine 123 whole body scintigram for patients of radioiodine therapy |
| Date of disclosure of the study information | 2014/11/10 |
| Last modified on | 2017/11/08 14:58:08 |
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Basic information
Public title
Study for usefulness of iodine 123 whole body scintigram for patients of radioiodine therapy
Acronym
iodine 123 test
Scientific Title
Study for usefulness of iodine 123 whole body scintigram for patients of radioiodine therapy
Scientific Title:Acronym
iodine 123 test
Region
| Japan |
Condition
Condition
thyroid cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the lesion detectability and predictive ability of treatment of whole body iodine 123 scan compared to conventional method
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
difference of lesion detectability between iodine131 scintigraphy and iodine 123 scintigraphy
Key secondary outcomes
difference of diagnostic performance and ROC curve
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Administration of I 123
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who is schedule to receive radio iodine therapy and have distant metastasis
2) Equal or over 20 y.o and sex is not concerned
3) Patient with documented IC
Key exclusion criteria
1) Patients for thyroid bed ablation
2) Those can not keep at rest during the scan
3) Patients with underage
4) Bad general condition PS=3 or more
5) Patients with pregnancy
6) Those can not sign to IC
7) Patients with bad renal function (CCr=1.5 or more), or patient undergoing blood dialysis
8) Patients who is thought to be inappropriate
by researcher.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hondaa |
Organization
Graduate school of medical sciences Kyushu University
Division name
department of clinical radiology
Zip code
Address
3-1-1 Maidashi Higashiku Fukuoka
TEL
092-642-5695
honda@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Baba |
Organization
Kyushu University Hospital
Division name
Clinical Radiology
Zip code
Address
3-1-1 Maidashi Higashiku Fukuoka
TEL
092-642-5695
Homepage URL
sbaba127@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2014 | Year | 11 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 25 | 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
| 2014 | Year | 11 | Month | 05 | Day |
Last modified on
| 2017 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018133
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
