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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015606
Receipt No. 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

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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
Last 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
Email honda@radiol.med.kyushu-u.ac.jp

Public contact
1st 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
Email sbaba127@radiol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018133

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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