UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029770 |
|---|---|
| Receipt number | R000034012 |
| Scientific Title | Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oropharyngeal cancers -a phase I study- |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/05/10 11:59:24 |
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Basic information
Public title
Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oropharyngeal cancers -a phase I study-
Acronym
Detection of sentinel lymph nodes with ultrasonography in oropharyngeal cancers, a phase I study
Scientific Title
Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oropharyngeal cancers -a phase I study-
Scientific Title:Acronym
Detection of sentinel lymph nodes with ultrasonography in oropharyngeal cancers, a phase I study
Region
| Japan |
Condition
Condition
Oropgaryngeal Cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Adverse Events
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events due to ultrasonography with sonazoid, SN detection rate
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
| Device,equipment |
Interventions/Control_1
Detection of SN and its blood flow with contrast enhanced ultrasonography
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) cNo with CT and/or US
2) No history for treatment of oropharyngeal cancer
3) 18 years old or older
4) written informed consent
Key exclusion criteria
1) Recurrent cases
2) history of irradiation for neck disease
3) history of treatment before surgery of this time
4) allergy for sonazoid
5) allergy for egg
6) pregnancy
7) Doctors did no approve the continuing the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiro Wakisaka |
Organization
Knazawa University Hospital
Division name
Otolaryngology, and Head & Neck Surgery
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2413
jibiinnfo@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiro Wakisaka |
Organization
Knazawa University Hospital
Division name
Otolaryngology, and Head & Neck Surgery
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2413
Homepage URL
jibiinnfo@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Knazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
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
Address
Tel
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 | 11 | 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
Sentinel lymph nodes were detected in
three out of four cases.
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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Transferred to the other data base
Management information
Registered date
| 2017 | Year | 10 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034012
