UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011729
Receipt number R000013714
Scientific Title Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion
Date of disclosure of the study information 2013/09/13
Last modified on 2013/09/12 14:15:22

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Basic information

Public title

Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion

Acronym

Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion

Scientific Title

Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion

Scientific Title:Acronym

Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion

Region

Japan


Condition

Condition

head and neck cancer

Classification by specialty

Oto-rhino-laryngology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess usefulness of contrast enhanced ultrasonography for identification of sentinel lymph node in patient with head and neck cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ultrasonographic findings of sentinel lymphography

Key secondary outcomes



Base

Study type


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

Prevention

Type of intervention

Medicine

Interventions/Control_1

injection of contrast enhanced material for ultrasonography into the lesion of the patients

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

Untreated patients with head and neck cancer
patients who is over 20 years old and is scheduled surgery for head and neck cancer

Key exclusion criteria

patient with allergy to contrast enhanced material for ultrasonography

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iida Etsushi

Organization

Yamaguchi University Hospital

Division name

Radiology

Zip code


Address

1-1-1 Minamikogushi Ube Yamaguchi

TEL

0836-22-2283

Email

iida2283@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Iida Etsushi

Organization

Yamaguchi University Hospital

Division name

Radiology

Zip code


Address

1-1-1 Minamikogushi Ube Yamaguchi

TEL

0836-22-2283

Homepage URL


Email

iida2283@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University Hospital

Institute

Department

Personal name



Funding Source

Organization

department of radiology, school of medicin, Yamaguchi University

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


Email



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

2013 Year 09 Month 13 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

Open public recruiting

Date of protocol fixation

2011 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 12 Day

Last modified on

2013 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013714


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name