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

Transthoracic Needle Biopsy for the Diagnosis of Pulmonary Nodule Using Three-dimensional Printed Navigational Template: A Phase I Feasibility Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03325907

Enrollment

Registered

2017-10-30

Start date

2020-06-01

Completion date

2020-09-03

Last updated

2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Biopsy, Needle, Printing, Three-Dimensional, Image-Guided Biopsy

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.

Interventions

DEVICEnavigational template

The navigational template was created based on computed tomography data using three-dimensional technology.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Intervention model description

single-armed feasibility trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026