UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dual energy CT evaluation of tumor hypoxia in lung cancer
Title of the study (Brief title)	Dual energy CT evaluation of tumor hypoxia in lung cancer
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of tumor hypoxia in lung cancer using dual energy contast enhanced CT
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	CT images
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	Other
Interventions/Control_1	aquisition of CT image
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	1)diagnosis of lung cancer 2)surgical resection indicated 3)contrast material administrable 4)written informed consent 5)PS0-1
Key exclusion criteria	1)unable to withhold breath 2)iodone allergy 3)others
Target sample size	50

Research contact person
Name of lead principal investigator	Mitsuo Nakayama
Organization	Saitama Medical Center, Saitama Medical University
Division name	Thoracic surgery
Address	1981 Kamoda, Kawagoeshi, saitama, japan
TEL	0492283459
Email	30mnaka@saitama-med.ac.jp

Public contact
Name of contact person	Mitsuo Nakayama
Organization	Saitama Medical Center, Saitama Medical University
Division name	Thoracic surgery
Address	1981 Kamoda, Kawagoeshi, saitama, japan
TEL	0492283459
Homepage URL
Email	30mnaka@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University,Saitama Medical Center
Institute
Department

Funding Source
Organization	Saitama Medical University,Saitama Medical Center
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	2014 Year 12 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 09 Day
Anticipated trial start date	2014 Year 12 Month 09 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	2014 Year 12 Month 09 Day
Last modified on	2018 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018479