Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial

Not Applicable

Completed

• Conditions: Lung Neoplasms
• Interventions: Device: navigational template

• Registration Number: NCT03325907
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

This study evaluates the feasibility of three-dimensional printed template in transthoracic pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy schedule to receive template-guided transthoracic needle aspiration.

Detailed Description

In previous study,a navigational template has been created to simplify the procedure of preoperative lung nodule localization. It was reported that localizer deviation was 10(0-20)mm.In this trial,Investigator explores the utility of this navigational template in transthoracic lung nodule biopsy.

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-30
• Study Start: 2020-06-01
• Primary Completion: 2020-08-03
• Study Completion: 2020-09-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

CT confirmed peripheral lung nodule; Nodule size larger than or equal to 3 cm; ECOG Performance Status 0-2 ; Informed consent.

Exclusion Criteria

Nodule located in the scapula region wherein biopsy needle is impeded; Nodule within 3 cm above diaphragmatic dome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
template-guided biopsy	navigational template	Participants receive transthoracic lung biopsy guided by navigational template.

Primary Outcome Measures

Name	Time	Method
Success rate of needle insertion	15 minutes	Clinician evaluate the relative position between biopsy needle and the target lesion on CT images after needle insertion.

Secondary Outcome Measures

Name	Time	Method
procedural length	1 hour	The length of procedural time is measured from the time a patient is lying on the examining bed of the CT scanner to the time he/she complete the biopsy procedure and step off the CT table.
radiation dosage	1 hour	How much radiation exposure patients would receive in the whole process of transthoracic needle biopsy.

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China