UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Indocyanine-assisted pulmonary metastasectomy
Title of the study (Brief title)	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	Fengshi Chen
Organization	Kyoto University, Graduate School of Medicine
Division name	Thoracic Surgery
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	Fengshi Chen
Organization	Kyoto University, Graduate School of Medicine
Division name	Thoracic Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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