UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of [11C]4DST PET in assessing malignancy of tumors
Title of the study (Brief title)	Utility of [11C]4DST PET in assessing malignancy of tumors
Region	Japan

Condition
Condition	Brain tumor, head and neck cancer, lung cancer, liver cancer, biliary tract cancer, pancreas cancer, musculoskeletal tumor, prostate cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Pneumology Oto-rhino-laryngology Orthopedics Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical utility of [11C]4DST PET in characterization and grading of various tumors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[11C]4DST uptake in tumors (visual assessment, SUV quantification, uptake count)
Key secondary outcomes	1) histological malignancy 2) FDG uptake in tumors

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	[11C]4DST PET/CT FDG PET/CT
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 have malignant tumors or are suspected to have malignant tumors. 2) Patients who agree and write informed consent form
Key exclusion criteria	1) Patients who are assumed to be difficult to implement the PET/CT examination due to general condition etc. 2) Women who are pregnant 3) Other patients who are judged inappropriate by research researcher, etc.
Target sample size	60

Research contact person
Name of lead principal investigator	Toshiyuki Saginoya
Organization	Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Division name	PET center
Address	7-161 Yatsuyamada, Koriyama, Fukushima
TEL	024-934-5432
Email	toshiyuki.saginoya@mt.strins.or.jp

Public contact
Name of contact person	Yoshihiro Eto
Organization	Southern TOHOKU Research Institute for Neuroscience
Division name	Corporate head office
Address	7-115 Yatsuyamada, Koriyama, Fukushima
TEL	024-934-5322
Homepage URL
Email	yoshihiro.eto@mt.strins.or.jp

Sponsor
Institute	Southern TOHOKU Research Institute for Neuroscience
Institute
Department

Funding Source
Organization	Southern TOHOKU Research Institute for Neuroscience
Organization
Division
Category of Funding Organization	Non profit foundation
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	2019 Year 02 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 02 Month 17 Day
Anticipated trial start date	2017 Year 03 Month 03 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	2019 Year 02 Month 20 Day
Last modified on	2019 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040951