UMIN-CTR Clinical Trial

Basic information
Public title	dynamic study of FDG-PET/CT and MET-PET/CT in evaluation of cervical lymph node
Acronym	PET/CT in evaluation of cervical lymph node
Scientific Title	dynamic study of FDG-PET/CT and MET-PET/CT in evaluation of cervical lymph node
Scientific Title:Acronym	PET/CT in evaluation of cervical lymph node
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology Radiology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the early and delayed phases of FDG-PET/CT and MET-PET/CT for the patient that head and neck cancer with lymph node metastasis is suspected. To evaluate the diagnostic ability in the detection of neck lymph node metastasis by addition of the early and delayed phases.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To be able to predict the histology of lesions by dynamic uptake pattern in the lesions obtained by addition of early and delayed phase.
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	Other
Interventions/Control_1	Addition of early and delayed phases of FDG-PET/CT and MET-PET/CT to usual imaging.
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	4 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients that head and neck cancer with neck lymph node metastasis is suspected
Key exclusion criteria	Patients with much body movement
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Harada
Organization	Tokushima University Hospital
Division name	Radiology
Zip code	7708503
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	088-631-3111
Email	otomi.yoichi@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Yoichi Middle name Last name Otomi
Organization	Tokushima University Hospital
Division name	Radiology
Zip code	7708503
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	088-631-3111
Homepage URL
Email	otomi.yoichi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Funding Source
Organization	JSPS KAKENHI Grant Number 17K16449
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokushima University Hospital
Address	2-50-1, Kuramoto-cho, Tokushima
Tel	088-633-9294
Email	awachiken@tokushima-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	2017 Year 08 Month 01 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	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB	2017 Year 07 Month 20 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2021 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031458