UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of pulmonary nodules by using CT perfusion technique
Title of the study (Brief title)	Evaluation of pulmonary nodules by using CT perfusion technique
Region	Japan

Condition
Condition	pulmonary nodular lesion
Classification by specialty	Pneumology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Differentiating benign or malignant lesion by CT perfusion study using dynamic contrast enhancement for nodular lesions smaller than 3 centimeters.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Correlation between perfusion dynamics of nodular lesion and histopathologic diagnosis
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Device,equipment
Interventions/Control_1	CT perfusion study by dynamic contrast enhancement
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have pulmonary nodular lesion smaller than 3 centimeters
Key exclusion criteria	Patient younger than 40 years old Contraindication of contrast agent such as allergy, severe renal dysfunction, etc.
Target sample size	60

Research contact person
Name of lead principal investigator	Fumikazu Sakai
Organization	Saitama Medical University International Medical Center
Division name	Department of Diagnostic Radiology
Address	1397-1, Yamane, Hidaka, Saitama
TEL	042-984-4520
Email	fmksakai@saitama-med.ac.jp

Public contact
Name of contact person	Fumikazu Sakai
Organization	Saitama Medical University International Medical Center
Division name	Department of Diagnostic Radiology
Address	1397-1, Yamane, Hidaka, Saitama
TEL	042-984-4520
Homepage URL
Email	fmksakai@saitama-med.ac.jp

Sponsor
Institute	Department of Diagnostic Radiology, Saitama Medical University International Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	nothing
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	埼玉医科大学国際医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2009 Year 10 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2009 Year 10 Month 14 Day
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2011 Year 10 Month 01 Day
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	2009 Year 10 Month 29 Day
Last modified on	2016 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003285