UMIN-CTR Clinical Trial

Public title

Clinical study of intraoperative pulmonary sentinel lymph nodes mapping using Vitamin B2 for lung cancer surgery

Acronym

Sentinel lymph nodes mapping using Vitamin B2

Scientific Title

Clinical study of intraoperative pulmonary sentinel lymph nodes mapping using Vitamin B2 for lung cancer surgery

Scientific Title:Acronym

Sentinel lymph nodes mapping using Vitamin B2

Region

Japan

Condition

Lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Based on the fact that vitamin B2 is a fluorescent substance, we developed a diagnostic method for sentinel lymph node, which is the first lymph node to which lung cancer metastasis spreads, using fluorescence endoscopy to visually confirm vitamin B2 as it is absorbed and transported through lymphatic system. In this study, we will consider the safety and usefulness of this method with the aim of evaluating the practicality of using it for humans.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety: Onset of an adverse event

Key secondary outcomes

1) Possibility to identify sentinel lymph node
2) Sensitibity, specificity, positive predictive value, negative predictive value
to identify sentinel lymph node

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Device,equipment

Interventions/Control_1

1) Vitamin B2, a fluorescent substance
2) Fluorescence endoscopy

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

Cases where a definitive diagnosis of non small cell pulmonary carcinoma has been obtained prior to surgery.

Cases which belong to a clinical stage of 1A to 3B, where complete resection is expected to be carried out.

Cases with no previous history of other malignant tumors.

Cases with no previous history of treatment for lung cancer, such as radiation or chemotherapy, prior to surgery.

Cases not accompanied by inflammatory conditions, such as pneumonia and pleurisy.

Cases involving patients between the ages of 20 and 75 years with an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1.

Cases with no history of bronchial asthma or serious drug allergy.

Cases with normal bone marrow, liver and kidney function.

Cases with no serious complication involving respiratory or cardiac function and that can withstand surgery.

Cases where written consent has been obtained from the patient with regard to participating in the trial.

Key exclusion criteria

Cases with cardiovascular disease that requires treatment, interstitial pneumonia, severe pulmonary emphysema, or impaired liver or kidney function.

Cases where it is impossible to perform lung lobe resection and systemic lymph node dissection due to problems with respiratory function or for other reasons.

Cases involving pregnant or lactating women.

Cases where the lead physician has determined that there is a problem with regard to performing surgery.

Cases where the administration of vitamin B2 has been known to cause some abnormality.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Masaya Tamura

Organization

Kanazawa University School of Medicine

Division name

Department of General Thoracic surgery

Zip code

Address

Takara-machi 13-1, Kanazawa

TEL

+81-076-265-2000

Email

mtamura@med.kanazawa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Masaya Tamura

Organization

Kanazawa University School of Medicine

Division name

Department of General Thoracic surgery

Zip code

Address

Takara-machi 13-1, Kanazawa

TEL

+81-076-265-2000

Homepage URL

Email

mtamura@med.kanazawa-u.ac.jp

Institute

Kanazawa University School of Medicine

Institute

Department

Personal name

Organization

Kanazawa University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

01

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2016

Year

10

Month

08

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

01

Month

23

Day

Last modified on

2017

Year

01

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029535