UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029631
Receipt number R000033850
Scientific Title Exploratory Study on identification of the position of the lung cancer Using PINPOINT Endoscopic Fluorescence Imaging System in thoracic Surgery
Date of disclosure of the study information 2017/11/01
Last modified on 2019/05/06 15:08:37

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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

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

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 or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033850


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name