UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion:single-center, single-arm, open-label, prospective, first-in-human, feasibility trial
Title of the study (Brief title)	CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion
Region	Japan

Condition
Condition	cancer
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Surgery in general Hepato-biliary-pancreatic surgery Chest surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Feasibility of CT fluoroscopy-guided biopsy with Zerobot
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Feasibility of CT fluoroscopy-guided biopsy with Zerobot, which is evaluated by inserting a biopsy introducer needle into the lesion or near the lesion on CT images
Key secondary outcomes	Safety of CT fluoroscopy-guided biopsy with Zerobot, which is evaluated by adverse events and machine trouble of throbot

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	1 day, 1 time
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patients who have a target lesion for which pathological diagnosis is required 2) patients with platelet count > 30,000/mm3 3) patients with PT-INR < 1.5 4) patients of 20-years-old or older 5) patients for whom informed consent is obtained 6) patients with a target lesion of at least 10-mm in diameter 7) patients with needle insertion length < 11 cm
Key exclusion criteria	1) patients who cannot limit body motion or hold their breath 2) patients whose needle tract for a target lesion is near (<10 mm) organs at risk such as the heart and aorta, gastrointestinal tract, pancreas, etc 3) patients who cannot stop antiplatelet or anticoagulant agents 4) patients who cannot undergo anesthesia 5) patients whose target lesion is in the head and neck, central nerve system, spinal cord, heart or aorta, and gastrointestinal tract 6) patients in whom the bone is an obstacle in needle tract 7) patients who undergo biopsy with other methods during study period 8) patients who undergo invasive therapy including chemotherapy, radiation, and surgery during study period 9) patients with mental disorder under treatment 10) pregnant patients 11) patients whom a physician judgesto be inappropriate 1
Target sample size	10

Research contact person
Name of lead principal investigator	Tako Hiraki
Organization	Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Radiology
Address	Kitaku, Shikatacho 2-5-1, Okayama
TEL	086-235-7313
Email	takaoh@tc4.so-net.ne.jp

Public contact
Name of contact person	Tako Hiraki
Organization	Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Radiology
Address	Kitaku, Shikatacho 2-5-1, Okayama
TEL	086-235-7313
Homepage URL
Email	takaoh@tc4.so-net.ne.jp

Sponsor
Institute	Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
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 11 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 18 Day
Anticipated trial start date	2018 Year 04 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	2017 Year 11 Month 17 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033852