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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024704
Receipt No. R000028423
Scientific Title Evaluation of the efficacy of contrast-enhanced ultrasonography for cervical lymph nodes of head and neck cancer patients
Date of disclosure of the study information 2016/11/03
Last modified on 2019/05/08

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Basic information
Public title Evaluation of the efficacy of contrast-enhanced ultrasonography for cervical lymph nodes of head and neck cancer patients
Acronym JHNCURG STUDY1
Scientific Title Evaluation of the efficacy of contrast-enhanced ultrasonography for cervical lymph nodes of head and neck cancer patients
Scientific Title:Acronym JHNCURG STUDY1
Region
Japan

Condition
Condition Head and Neck Cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safety of contrast-enhancement of the lymph nodes of head and neck cancer patients who would undergo neck dissection or extirpation of the lymph nodes using two different doses of Sonazoid.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes To assess the efficacy of contrast-enhanced ultrasonography compared with the B-mode ultrasonography in depicting ability of micro-vessels.
Key secondary outcomes 1. Evaluation of the diagnostic imaging comparing with contrast-enhanced CT or contrast-enhanced MRI.
2. Evaluation of contrast-enhanced effects.

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
Interventions/Control_1 Contrast-enhanced ultrasonography using micro-bubble contrast-enhanced agent.
Only one diagnostic procedure before surgery.
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. Patients with untreated tumor (lymph node = interest lesion) depicted by other diagnostic modalities such as CT, MRI and FDG-PET or palpation and so on.
2. Patients who are subjected to undergo histopathological examination of interest lesions.
Key exclusion criteria 1. Allergy to eggs or egg products
2. Right to left shunts in heart or lung
3. Severe heart diseases
4. Severe lung diseases
5. Patients who plan to undergo digestive tract examination on the same day of contrast-enhanced ultrasonography
6. Pregnancy and possibility of the pregnancy or patients under the nursing
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kiyoto
Middle name
Last name Shiga
Organization Iwate Medical University, School of medicine
Division name Department of Head and Neck Surgery
Zip code 020-8505
Address 19-1 Uchimaru, Morioka
TEL 019-651-5111
Email kshiga@iwate-med.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Saito
Organization Iwate Medical University Hospital
Division name Department of Head and Neck Surgery
Zip code 020-8505
Address 19-1 Uchimaru, Morioka
TEL 019-651-5111
Homepage URL
Email daisaito@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee Iwate Medical University School of Medicine
Address 19-1 Uchimaru, Morioka
Tel 019-651-5111
Email hiroaki.kawamori@j.iwate-med.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
2016 Year 11 Month 03 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
2014 Year 12 Month 25 Day
Date of IRB
2015 Year 02 Month 05 Day
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2021 Year 12 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
2016 Year 11 Month 03 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028423

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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