UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	I-131 therapy for metastatic thyroid cancer with recombinant human thyroid-stimulating hormone (Thyrogen)
Title of the study (Brief title)	I-131 therapy for metastatic thyroid cancer with recombinant human thyroid-stimulating hormone
Region	Japan

Condition
Condition	Thyroid cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical efficacy of I-131 therapy with recombinant human thyroid-stimulating hormone in metastatic thyroid cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of anti-tumor effects with tumor uptake and tumor markers
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	recombinant human thyroid-stimulating hormone
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	16 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) a patient with distant metastases of thyroid cancer, who underwent total thyroidectomy or almost total thyroidectomy for differenciated thyroid cancer 2) a patient who underwent thyroidectomy before 6 weeks or more
Key exclusion criteria	1) a patient whose thyroid Ca has not able to uptake I-131 2) a patient with clitical disease 3) a patient who was administered an iodinated contrast agent 4) pregnant female and feeding female 5) when medical staff determine that treatment can not be properly carried out
Target sample size	10

Research contact person
Name of lead principal investigator	Atsutaka Okizaki
Organization	Asahikawa Medical University
Division name	Department of Radiology
Address	2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL	+166-68-2572
Email	okizaki@asahikawa-med.ac.jp

Public contact
Name of contact person	Atsutaka Okizaki
Organization	Asahikawa Medical University
Division name	Department of Radiology
Address	2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL	+166-68-2572
Homepage URL
Email	okizaki@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 05 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 16 Day
Anticipated trial start date	2014 Year 05 Month 16 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 05 Month 16 Day
Last modified on	2018 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016275