UMIN-CTR Clinical Trial

Basic information
Public title	Utility of 11C-Methionine PET in assessing malignancy of tumors
Acronym	Utility of 11C-Methionine PET in assessing malignancy of tumors
Scientific Title	Utility of 11C-Methionine PET in assessing malignancy of tumors
Scientific Title:Acronym	Utility of 11C-Methionine PET in assessing malignancy of tumors
Region	Japan

Condition
Condition	Brain tumor, Head and neck cancer, lung cancer, soft tissue tumor, pancreas cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Pneumology Oto-rhino-laryngology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical utility of 11C-Methionine 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	Methionine uptake in tumors (visual assessment, SUV quantification, uptake count)
Key secondary outcomes	1) histological malignancy 2) FDG uptake in tumors 3) ADC measurements by diffusion-weighted MRI

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-Methionine
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	10 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have malignant tumors or are suspected to have malignant tumors. Target disease: brain tumors, head and neck tumors, lung cancer, soft tissue tumor, pancreas cancer Patients who agree and write informed consent form Age >10 year-old If subjects are child, their parent or guardian write informed consent form
Key exclusion criteria	Pregnancy Claustrophobia Patient who can not keep still during the examination Performance Status >3 Patients who are not informed to have malignancy, if applicable MRI contradiction 1 Heart pacemaker 2 artificial ear 3 artificial hear valve 4 clip for cerebral aneurysm 5 artificial denture/implant 6 tattoo 7 other metals
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Honda
Organization	Kyushu University Hospital
Division name	Radiology
Zip code	812-8582
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	1st name Osamu Middle name Last name Togao
Organization	Kyushu University Hospital
Division name	Radiology
Zip code	812-8582
Address	3-1-1 Maidashi Higashiku, Fukuoka
TEL	092-642-5695
Homepage URL
Email	togao@radiol.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital, Department of Clinical Radiology
Institute
Department

Funding Source
Organization	Kyushu University Hospital, Department of Clinical Radiology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Radiology, Kyushu University
Address	3-1-1 Maidashi Higashiku Fukuoka Japan
Tel	092-642-5695
Email	togao.osamu.595@m.kyushu-u.ac.jp

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	2016 Year 01 Month 16 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	Preinitiation
Date of protocol fixation	2015 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date	2016 Year 01 Month 20 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	2016 Year 01 Month 15 Day
Last modified on	2021 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023760