UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for usefulness of iodine 123 whole body scintigram for patients of radioiodine therapy
Title of the study (Brief title)	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	Hiroshi Hondaa
Organization	Graduate school of medical sciences Kyushu University
Division name	department of clinical radiology
Address	3-1-1 Maidashi Higashiku Fukuoka
TEL	092-642-5695
Email	honda@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person	Shingo Baba
Organization	Kyushu University Hospital
Division name	Clinical Radiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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