UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024704
Receipt number 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 18:37:58

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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 or person

Institute

Iwate Medical University

Institute

Department

Personal name



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

Value
https://center6.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