UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of intraoperative pulmonary sentinel lymph nodes mapping using Vitamin B2 for lung cancer surgery
Title of the study (Brief title)	Sentinel lymph nodes mapping using Vitamin B2
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Masaya Tamura
Organization	Kanazawa University School of Medicine
Division name	Department of General Thoracic surgery
Address	Takara-machi 13-1, Kanazawa
TEL	+81-076-265-2000
Email	mtamura@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Masaya Tamura
Organization	Kanazawa University School of Medicine
Division name	Department of General Thoracic surgery
Address	Takara-machi 13-1, Kanazawa
TEL	+81-076-265-2000
Homepage URL
Email	mtamura@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University School of Medicine
Institute
Department

Funding Source
Organization	Kanazawa University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 01 Month 26 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 10 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 23 Day
Last modified on	2017 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029535