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
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
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
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
