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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325907
• Other study ID #: K17-155
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: September 3, 2020

Study information

• Verified date: February 2021
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhang L, Li M, Li Z, Kedeer X, Wang L, Fan Z, Chen C. Three-dimensional printing of navigational template in localization of pulmonary nodule: A pilot study. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2113-2119.e7. doi: 10.1016/j.jtcvs.2017.08.065. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of needle insertion	Clinician evaluate the relative position between biopsy needle and the target lesion on CT images after needle insertion.	15 minutes
Secondary	procedural length	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.	1 hour
Secondary	radiation dosage	How much radiation exposure patients would receive in the whole process of transthoracic needle biopsy.	1 hour