Lung NeoplasmNCT02952261
Application of 3D Printing Technique in Small Pulmonary Nodule Localization
A study testing template-guided localization and CT-guided localization in people with Lung Neoplasm and Thoracic Surgery, Video-Assisted, run by Chang Chen at 1 site in China.
Trial summary
The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Lung Neoplasm, Thoracic Surgery, Video-Assisted
- What is being tested?
- template-guided localization and CT-guided localization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2016to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 19 to 80 years
- lesions located in peripheral lung tissue which can be removed by wedge resection
- The maximum diameter of the lesion is no more than 20 mm.
- Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization
- Informed consent was signed voluntarily.
Who cannot join
- nodule located in the scapula region.
- there were two or more lung nodules needed to be localized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial
The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.
Read the detailed description
Localization of small lung nodule is challenging due to the difficulty of nodule recognition during VATS. A three-dimensional printed navigational template was designed to aid percutaneous lung nodule localization, and its feasibility has been confirmed in previous study. The trial was conducted to confirm the non-inferiority of template-guided method to conventional CT-guided method in terms of localization accuracy.
- Conditions
- Lung Neoplasm, Thoracic Surgery, Video-Assisted
- Being tested
- template-guided localization, CT-guided localization
- Keywords
- Printing, Three-dimensional
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
template-guided localizationDevice
Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization.
CT-guided localizationOther
Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
| Study group | Role | What they receive |
|---|---|---|
| CT-guided localization | Other | This group of participants received conventional CT-guided lung nodule localization. Receives: Other: CT-guided localization |
| template-guided localization | Experimental | Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization. Receives: Device: template-guided localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Lung Nodule Localization
Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)
Measured: From the time of completing final CT scan, assessed up to 2 days.
Secondary outcomes (3)
Procedural Duration of the Nodule Localization
Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan.
Measured: From the time of completing final CT scan, assessed up to 1 hour.
Radiation Dose
Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.
Measured: From the time of completing final CT scan, assessed up to 1 hour.
Complication Rate
Pnuemothorax related to lung nodule localization
Measured: From the time of completing final CT scan, assessed up to 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start24 Oct 2016
- Primary completion1 Oct 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Chang Chen, MD,Ph.D, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952261
- Sponsor's protocol ID
- k16-284
- Status last verified
- Dec 2018
- First submitted
- 31 Oct 2016
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 29017792Zhang L, Wang L, Kadeer X, Zeyao L, Sun X, Sun W, She Y, Xie D, Li M, Zou L, Rocco G, Yang P, Chen C, Liu CC, Petersen RH, Ng CSH, Parrish S, Zhang YS, Giordano R, di Tommaso L; AME Thoracic Surgery Collaborative Group. Accuracy of a 3-Dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2019 Apr 1;154(4):295-303. doi: 10.1001/jamasurg.2018.4872.
PubMed 30586136
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02952261
- Acronym / sponsor ID
- k16-284
- Conditions
- Lung Neoplasm, Thoracic Surgery, Video-Assisted
- Keywords
- Printing, Three-dimensional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chang ChenUniversity, hospital or other
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Posted 1 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.
Detailed description
Localization of small lung nodule is challenging due to the difficulty of nodule recognition during VATS. A three-dimensional printed navigational template was designed to aid percutaneous lung nodule localization, and its feasibility has been confirmed in previous study. The trial was conducted to confirm the non-inferiority of template-guided method to conventional CT-guided method in terms of localization accuracy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-guided localization | Other | Other: CT-guided localizationThis group of participants received conventional CT-guided lung nodule localization. |
| template-guided localization | Experimental | Device: template-guided localizationThree-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged from 19 to 80 years
- lesions located in peripheral lung tissue which can be removed by wedge resection
- The maximum diameter of the lesion is no more than 20 mm.
- Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization
- Informed consent was signed voluntarily.
Key exclusion criteria (2 listed)
- nodule located in the scapula region.
- there were two or more lung nodules needed to be localized.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| template-guided localizationBased on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization. | Device | template-guided localization |
| CT-guided localizationPercutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization. | Other | CT-guided localization |
Primary outcome
Accuracy of Lung Nodule Localization
Time frame: From the time of completing final CT scan, assessed up to 2 days.
Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)
3 secondary outcomes
Procedural Duration of the Nodule Localization
Time frame: From the time of completing final CT scan, assessed up to 1 hour.
Radiation Dose
Time frame: From the time of completing final CT scan, assessed up to 1 hour.
Complication Rate
Time frame: From the time of completing final CT scan, assessed up to 2 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29017792Zhang 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.
- Derived from this study: PubMed 30586136Zhang L, Wang L, Kadeer X, Zeyao L, Sun X, Sun W, She Y, Xie D, Li M, Zou L, Rocco G, Yang P, Chen C, Liu CC, Petersen RH, Ng CSH, Parrish S, Zhang YS, Giordano R, di Tommaso L; AME Thoracic Surgery Collaborative Group. Accuracy of a 3-Dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2019 Apr 1;154(4):295-303. doi: 10.1001/jamasurg.2018.4872.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Chen, MD,Ph.D principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing template-guided localization and CT-guided localization in people with Lung Neoplasm and Thoracic Surgery, Video-Assisted, run by Chang Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Lung Nodule Localization (time frame: From the time of completing final CT scan, assessed up to 2 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02952261, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.