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

NCT03325907 | Completed

• 1 other identifier: K17-155
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• procedural length

  1 hour

• radiation dosage

  1 hour

Study Arms (1)

template-guided biopsy

EXPERIMENTAL

Participants receive transthoracic lung biopsy guided by navigational template.

Device: navigational template

Interventions

navigational template DEVICE

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

template-guided biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (2)

• 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 2017 Sep 1.

  PMID: 29017792 RESULT

• E H, Chen J, Sun W, Zhang Y, Ren S, Shi J, Wen Y, Su C, Ni J, Zhang L, He Y, Chen B, Casal RF, Kheir F, Ishiwata T, Zhang J, Zhao D, Chen C. Three-dimensionally printed navigational template: a promising guiding approach for lung biopsy. Transl Lung Cancer Res. 2022 Mar;11(3):393-403. doi: 10.21037/tlcr-22-172.

  PMID: 35399565 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chang Chen, MD,Ph.D

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: single-armed feasibility trial

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 30, 2017
• Study Start: June 1, 2020
• Primary Completion: August 3, 2020
• Study Completion: September 3, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)