UMIN-CTR Clinical Trial

Public title

Feasibility study of fluorescence imaging for sentinel lymph node detection using indocyanine green in head and neck cancer.

Acronym

Fluorescence imaging for sentinel lymph node detection using ICG in head and neck cancer.

Scientific Title

Feasibility study of fluorescence imaging for sentinel lymph node detection using indocyanine green in head and neck cancer.

Scientific Title:Acronym

Fluorescence imaging for sentinel lymph node detection using ICG in head and neck cancer.

Region

Japan

Condition

Head and neck cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy of fluorescence imaging for sentinel lymph node biopsy using indocyanine green in head and neck cancer

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The detection accuracy of the sentinel lymph nodes

Key secondary outcomes

1. Complications
2. Metastasis of the regional lymph nodes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Device,equipment

Interventions/Control_1

Preoperative local injection of indocyanine green and indigocarmine and intraoperative fluorescence imaging

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients of head and neck cancer with the indication of elective neck dissection

Key exclusion criteria

1. Recurrent disease
2. Hypersensitivity to indocyanine green or indigocarmine
3. Poorly controlled hypertension
4. Women in pregnancy or breast-feeding

Target sample size

10

Name of lead principal investigator

1st name	Shunsuke
Middle name
Last name	Miyamoto

Organization

Kitasato University School of Medicine

Division name

Department of Otorhinolaryngology-Head and Neck Surgery

Zip code

252-0374

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN

TEL

042-778-8111

Email

s-miya@kitasato-u.ac.jp

Name of contact person

1st name	Shunsuke
Middle name
Last name	Miyamoto

Organization

Kitasato University School of Medicine

Division name

Department of Otorhinolaryngology-Head and Neck Surgery

Zip code

252-0374

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN

TEL

042-778-8111

Homepage URL

Email

s-miya@kitasato-u.ac.jp

Institute

Kitasato University School of Medicine, Department of Otorhinolaryngology-Head and Neck Surgery

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Kitasato University Medical Ethics Organization

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN

Tel

042-778-8111

Email

rinri-n@kitasato-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北里大学病院（神奈川県）

Date of disclosure of the study information

2020

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

8

Results

Sentinel lymph nodes were visualized in all eight cases. Two cases showed occult metastases on both sentinel and regional nodes. The identification and false negative rates were 100% and 0%, respectively. There were no complications incurred due to this method.

Results date posted

2020

Year

11

Month

01

Day

Results Delayed

Delay expected

Results Delay Reason

Under article submission

Date of the first journal publication of results

Baseline Characteristics

Seven with tongue cancer and one with tonsil cancer. All were diagnosed with squamous cell carcinoma at stage cT2. The median age of the patients was 63.5 years (range, 50-74 years).

Participant flow

All participants were monitored for a minimum of five years after the clinical trial.

Adverse events

Not applicable

Outcome measures

Efficacy and complications of sentinel lymph node detection using fluorescence imaging in head and neck cancer

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

08

Month

13

Day

Date of IRB

2012

Year

10

Month

24

Day

Anticipated trial start date

2012

Year

10

Month

24

Day

Last follow-up date

2017

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

01

Day

Last modified on

2020

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048300