UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory Study on identification of the position of the lung cancer Using PINPOINT Endoscopic Fluorescence Imaging System in thoracic Surgery
Acronym	Study on identification of the position of the lung cancer Using PINPOINT
Scientific Title	Exploratory Study on identification of the position of the lung cancer Using PINPOINT Endoscopic Fluorescence Imaging System in thoracic Surgery
Scientific Title:Acronym	Study on identification of the position of the lung cancer Using PINPOINT
Region	Japan

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

Objectives
Narrative objectives1	Using PINPOINT Endoscopic Fluorescence Imaging System, we will examine the visibility of ICG accumulated in lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visibility of ICG accumulation in lung cancer by PINPOINT Endoscopic Fluorescence Imaging System
Key secondary outcomes

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	ICG is intravenously administered at 0.25 - 0.5 mg / kg between 24 hours before the start of surgery and start of the operation. We will confirm accumulation of ICG in lung cancer with the ICG Endoscopic Fluorescence Imaging System after starting the operation.
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.Cases with age => 20 years (no upper limit is provided). 2.Cases in which functions of major organs are preserved. 3.Cases that an operation under the general anesthesia is possible. 4.A well-informed written consent was obtained from the patient
Key exclusion criteria	1.Pregnant or potentially women, nursing women 2.Past history of the open thoracotomy. 3.A patient with a history of hypersensitivity to the components of ICG or a patient with a history of iodine hypersensitivity. 4.Patients with psychiatric diseases. 5.Patients with severe or complicated medical conditions, not allowing participation into this protocol.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Yasuhiko Middle name Last name Ohshio
Organization	Shiga Univercity of Medical Science
Division name	Department of Chest Surgery
Zip code	5202192
Address	Seta Tsukinowa, Otsu ,Shiga ,JAPAN
TEL	077-548-2244
Email	yasuhiko@belle.shiga-med.ac.jp

Public contact
1st name of contact person	1st name Yasuhiko Middle name Last name Ohshio
Organization	Shiga University of Medical Science
Division name	Department of Chest Surgery
Zip code	5202192
Address	Seta Tsukinowa, Otsu ,Shiga ,JAPAN
TEL	077-548-2244
Homepage URL
Email	yasuhiko@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Seta Tsukinowa, Otsu ,Shiga ,JAPAN
Tel	0775483576
Email	yasuhiko@belle.shiga-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	2017 Year 11 Month 01 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	8
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	2017 Year 11 Month 01 Day
Date of IRB	2017 Year 10 Month 04 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 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	2017 Year 10 Month 19 Day
Last modified on	2019 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033850