UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027466 |
|---|---|
| Receipt number | 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 | 2021/12/03 09:17:52 |
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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
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
otomi.yoichi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031458
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
