UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027466
Receipt No. R000031458
Scientific Title dynamic study of FDG-PET/CT and MET-PET/CT in evaluation of cervical lymph node
Date of disclosure of the study information 2017/08/01
Last modified on 2019/05/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 No longer recruiting
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
2019 Year 05 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.