UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope for preoperative lung cancer patients
Title of the study (Brief title)	CTLG with bronchoalveolar injection of iopamidol using ultrathin bronchoscope
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	validity of computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope for preoperative lung cancer patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	detection rate of sentinel lymph node
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	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope
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	preoperative clinical stage IA patients
Key exclusion criteria	high risk patients for curative operation, allergy to iodine
Target sample size	50

Research contact person
Name of lead principal investigator	Hiromitsu Takizawa
Organization	Tokushima University Hospital
Division name	Department of Thoracic Surgery
Address	3-18-15, Kuramotocho, Tokushima city, Tokushima, Japan
TEL
Email

Public contact
Name of contact person
Organization	The University of Tokushima Graduate School
Division name	Department of Thoracic, Endocrine Surgery and Oncology
Address
TEL
Homepage URL
Email	htakizawa@clin.med.tokushima-u.ac.jp

Sponsor
Institute	Department of Thoracic, Endocrine Surgery and Oncology, The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2010 Year 03 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2010 Year 01 Month 15 Day
Anticipated trial start date	2010 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	2010 Year 02 Month 18 Day
Last modified on	2018 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003880