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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025816
Receipt No. R000029535
Scientific Title Clinical study of intraoperative pulmonary sentinel lymph nodes mapping using Vitamin B2 for lung cancer surgery
Date of disclosure of the study information 2017/01/26
Last modified on 2017/01/23

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Basic information
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
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
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

Public contact
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

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)

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
2017 Year 01 Month 26 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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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