CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy

A Single-center, Randomized, Active-controlled and Evaluator-blind Investigator-initiated Trial to Evaluate and Compare the Efficacy and Safety of CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Patients Scheduled to Undergo Percutaneous Pulmonary Nodule Biopsy

The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to undergo percutaneous pulmonary nodule biopsy.

Study Overview

• Status: Unknown
• Conditions: Percutaneous Pulmonary Nodule Biopsy
• Intervention / Treatment: Device: stereotaxic unit, navigation; Device: conventional biopsy technique

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT
• Histopathologic examination is necessary if lung lesion is unknown
• Histologic findings affect the disease stage or treatment plan
• If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit
• Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure)
• Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol

Exclusion Criteria:

• Patient with pulmonary function insufficiency
• Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus)
• Patient with Uncontrolled coagulation disorders (INR > 1.3 or Blood platelet count < 50,000/µl)
• Patient with allergy to CT contrast agent
• Patient under 19 years old or over 80 years old
• Pregnant or lactating
• Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.)
• Patient who currently participating or has participated in other clinical trials within 30 days of the screening date
• If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotaxic unit, navigation	Device: stereotaxic unit, navigation; CT-guided needle guidance using stereotaxic unit, navigation
Active Comparator: Conventional biopsy technique	Device: conventional biopsy technique; CT-guided needle guidance using conventional biopsy technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle guide accuracy(mm)	3D distance between target point and actual needle tip	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle guide angle deviation(°)	The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle	1 day
Number of needle readjustments	Retract the inserted needle and adjust the direction	1 day
Number of needle reinsertion	Needle is completely pulled out and then inserted again	1 day
Needle insertion time(min)	Time from pre-CT scan to the last CT scan before lung biopsy	1 day
Procedure time(min)	Time from pre-CT scan to dressing after lung biopsy	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation dose(DLP, mGy·cm)	DLP(mGy·cm) = CTDIvol x scan length	1 day
Occurrence rate of adverse device effect(%)	Adverse events that are correlated with the needle insertion procedure	1 month

Collaborators and Investigators

• Sponsor: Hyung Jin Won
• Investigators: Principal Investigator: Hyung Jin Won, MD., PhD, Asan medical center, Seoul, Korea

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: AS-NPR-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No