UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000028423