UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective investigation of C-11 methionine PET/CT for soft tissue tumor
Title of the study (Brief title)	Prospective investigation of C-11 methionine PET/CT for soft tissue tumor
Region	Japan

Condition
Condition	Soft tissue tumor
Classification by specialty	Orthopedics Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this prospective study is to assess the amino acid metabolism in soft tissue tumor and internal organs with C-11 methionine PET/CT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The correlation between C-11 methionine uptake to the soft tissue tumor and histological findings.
Key secondary outcomes	The comparison between C-11 methionine PET/CT and other imaging modalities in patients with soft tissue tumor. The assessment of the C-11 methionine uptake to internal organs by multiple-time-point PET/CT.

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	Preoperative examination of C-11 methionine PET/CT(C-11 methionine 3.7MBq/kg)(until March 31, 2021)
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	3 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with suspected soft tissue tumor who are to be operated.
Key exclusion criteria	Baby and toddler (under 3 years olds). Pregnant female. Nursing woman.
Target sample size	100

Research contact person
Name of lead principal investigator	Masafumi Harada
Organization	Tokushima university hospital
Division name	Department of radiology
Address	Kuramotocho 2-50-1, Tokushima-city
TEL	088-633-7173
Email	shinya.takayoshi@tokushima-u.ac.jp

Public contact
Name of contact person	Yoichi Otomi
Organization	Tokushima university hospital
Division name	Department of radiology
Address	Kuramotocho 2-50-1, Tokushima-city
TEL	088-633-7173
Homepage URL
Email	otomi.yoichi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima university hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 28 Day
Anticipated trial start date	2015 Year 09 Month 29 Day
Last follow-up date
Date of closure to data entry	2021 Year 03 Month 31 Day
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	2015 Year 08 Month 27 Day
Last modified on	2018 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021768