UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of an aspiration-type semiautomatic cutting biopsy needle in percutaneous image-guided biopsy: A prospective clinical study
Title of the study (Brief title)	SCIRO-1702
Region	Japan

Condition
Condition	Lung mass, Renal mass
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of an aspiration-type semiautomatic cutting biopsy needle for obtaining larger specimens by comparing the weight of the specimens obtained with and without aspiration.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference of the weight between the biopsy specimens obtained with and without aspiration.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	The first specimen is obtained with aspiration and the second without aspiration.
Interventions/Control_2	The first specimen is obtained without aspiration and the second with aspiration.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients indicated for percutaneous image-guided biopsy for histological diagnosis of lung or renal lesions. 2. The long axis diameter of the target lesion is more than 1.0 cm. 3. The patient is equal to or more than 20 years old. 4. Written informed consent for participation to this research is obtained from the patient.
Key exclusion criteria	1. The target lesion appears ground-glass opacity on high-resolution CT. 2. The target site of the lesion includes necrotic portion. 3. Inadequate coagulation or bone marrow function. 4. The patient is confirmed or suspected of being pregnant. 5. The patient has mental disorders including dementia.
Target sample size	75

Research contact person
Name of lead principal investigator	Yusuke Matsui
Organization	Okayama University Medical School
Division name	Department of Radiology
Address	2-5-1 Shikatacho, Kita-ku, Okayama, Japan
TEL	086-235-7313
Email	y-matsui@okayama-u.ac.jp

Public contact
Name of contact person	Yusuke Matsui
Organization	Okayama University Medical School
Division name	Department of Radiology
Address	2-5-1 Shikatacho, Kita-ku, Okayama, Japan
TEL	086-235-7313
Homepage URL
Email	radiol@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Japan Radiological Society
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	2017 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 07 Month 03 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 05 Month 21 Day
Last modified on	2018 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030615