Back to resultsTransthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial
Primary Purpose
Lung Neoplasms
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
navigational template
Sponsored by
About this trial
This is an interventional device feasibility trial for Lung Neoplasms focused on measuring Biopsy, Needle, Printing, Three-Dimensional, Image-Guided Biopsy
Eligibility Criteria
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.
Sites / Locations
- Shanghai Pulmonary Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
template-guided biopsy
Arm Description
Participants receive transthoracic lung biopsy guided by navigational template.
Outcomes
Primary Outcome Measures
Success rate of needle insertion
Clinician evaluate the relative position between biopsy needle and the target lesion on CT images after needle insertion.
Secondary Outcome Measures
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.
radiation dosage
How much radiation exposure patients would receive in the whole process of transthoracic needle biopsy.
Full Information
NCT ID
NCT03325907
First Posted
October 26, 2017
Last Updated
February 24, 2021
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
1. Study Identification
Unique Protocol Identification Number
NCT03325907
Brief Title
Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial
Official Title
Transthoracic Needle Biopsy for the Diagnosis of Pulmonary Nodule Using Three-dimensional Printed Navigational Template: A Phase I Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
September 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Biopsy, Needle, Printing, Three-Dimensional, Image-Guided Biopsy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-armed feasibility trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
template-guided biopsy
Arm Type
Experimental
Arm Description
Participants receive transthoracic lung biopsy guided by navigational template.
Intervention Type
Device
Intervention Name(s)
navigational template
Intervention Description
The navigational template was created based on computed tomography data using three-dimensional technology.
Primary Outcome Measure Information:
Title
Success rate of needle insertion
Description
Clinician evaluate the relative position between biopsy needle and the target lesion on CT images after needle insertion.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
procedural length
Description
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.
Time Frame
1 hour
Title
radiation dosage
Description
How much radiation exposure patients would receive in the whole process of transthoracic needle biopsy.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Chen, MD,Ph.D
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29017792
Citation
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.
Results Reference
result
PubMed Identifier
35399565
Citation
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.
Results Reference
derived
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Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial
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