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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026120
Receipt No. R000028554
Scientific Title Indocyanine-assisted pulmonary metastasectomy
Date of disclosure of the study information 2017/03/01
Last modified on 2018/05/08

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Basic information
Public title Indocyanine-assisted pulmonary metastasectomy
Acronym Indocyanine-assisted pulmonary metastasectomy
Scientific Title Indocyanine-assisted pulmonary metastasectomy
Scientific Title:Acronym Indocyanine-assisted pulmonary metastasectomy
Region
Japan

Condition
Condition pulmonary metastasis
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of administering preoperatively intravenous indocyanine green in patients undergoing pulmonary metastasectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Whether pulmonary metasases that are identified on preoperative radiological workup are enhanced by indocyanine green.
Key secondary outcomes Whether any lesion that is not identified on preoperative radiological workup is enhanced by indocyanine green and consistent with pulmonary metastasis.

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 12-24 hours prior to the operation, 2mg/kg of indocyanine green is administered intravenously via a peripheral vein in a patient's room. In an operating room, using Infrared observation camera system, we judge whether metastatic lesions emit fluorescence or not.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have pulmonary metastases that appear palpable intraoperatively, and were resectable and surgically indicated.
Key exclusion criteria Patients who have pulmonary metastases that do not appear palpable intraoperatively, those who are allergic to indocyanine green or iodine preparation.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fengshi Chen
Organization Kyoto University, Graduate School of Medicine
Division name Thoracic Surgery
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4975
Email fengshic@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fengshi Chen
Organization Kyoto University, Graduate School of Medicine
Division name Thoracic Surgery
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4975
Homepage URL
Email fengshic@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyoto University, Graduate 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 03 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
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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 03 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 02 Month 13 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028554

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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