UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026120 |
|---|---|
| Receipt number | R000028554 |
| Scientific Title | Indocyanine-assisted pulmonary metastasectomy |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2018/05/08 12:31:54 |
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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
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
fengshic@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028554
