UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of cell proliferation using FLT-PET for FDG-avid parotid tumor
Title of the study (Brief title)	FLT-PET for FDG-avid parotid tumor
Region	Japan

Condition
Condition	Parotid tumor
Classification by specialty	Oto-rhino-laryngology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical value of FLT-PET for the patients with FDG-avid parotid tumor
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between FLT uptake and clinical diagnosis / FDG uptake
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	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	FLT-PET
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. FDG-PET was performed within 2 months before entering this study 2. FDG-avid parotid tumor was pointed out, and examined at otorhinolaryngology department of KCMCGH 3. Diameter of the parotid tumor was 1cm or more confirmed by CT / MRI / US 4. Patients understood well their condition of the disease
Key exclusion criteria	1. Poor general condition 2. Cannot keep supine position for 60 minutes 3. Pregnant or possibility of pregnancy 4. Severe claustrophobia 5. Regarded as unsuitable by responsible investigators
Target sample size	10

Research contact person
Name of lead principal investigator	Michio Senda
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Molecular Imaging
Address	2-2, Minatojima-Minamimachi, Chuo-Ku, Kobe
TEL
Email

Public contact
Name of contact person
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Molecular Imaging
Address	2-2, Minatojima-Minamimachi, Chuo-Ku, Kobe
TEL	078-306-1700
Homepage URL
Email

Sponsor
Institute	Foundation of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization	Foundation of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 06 Month 15 Day
Anticipated trial start date	2011 Year 07 Month 01 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	2011 Year 06 Month 23 Day
Last modified on	2016 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006841