Trial Outcomes & Findings for Application of 3D Printing Technique in Small Pulmonary Nodule Localization (NCT NCT02952261)
NCT ID: NCT02952261
Last Updated: 2018-12-19
Results Overview
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.)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
From the time of completing final CT scan, assessed up to 2 days.
Results posted on
2018-12-19
Participant Flow
The recruitment process was from October 15, 2016 to October 26, 2017. And, the first participant was recruited on October 24, 2016. Until reaching to 40% of prespecified sample size (Janunary 1, 2017) , interim analysis was conducted.
Participant milestones
| Measure |
CT-guided Localization
This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
|
Template-guided Localization
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
95
|
95
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
CT-guided Localization
This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
|
Template-guided Localization
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CT-guided Localization
n=100 Participants
This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
|
Template-guided Localization
n=100 Participants
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: 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.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 11 • n=100 Participants
|
54 years
STANDARD_DEVIATION 15 • n=100 Participants
|
53 years
STANDARD_DEVIATION 13 • n=200 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=100 Participants
|
74 Participants
n=100 Participants
|
147 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=100 Participants
|
26 Participants
n=100 Participants
|
53 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Smoking history
YES
|
28 Participants
n=100 Participants
|
30 Participants
n=100 Participants
|
58 Participants
n=200 Participants
|
|
Smoking history
NO
|
72 Participants
n=100 Participants
|
70 Participants
n=100 Participants
|
142 Participants
n=200 Participants
|
|
BMI(body mass index)
|
22.9 Kg/m^2
STANDARD_DEVIATION 2.9 • n=100 Participants
|
22.8 Kg/m^2
STANDARD_DEVIATION 2.8 • n=100 Participants
|
22.9 Kg/m^2
STANDARD_DEVIATION 2.8 • n=200 Participants
|
|
FEV1（of percentage predicted）
|
93.6 Percentage predicted FEV1
STANDARD_DEVIATION 13.0 • n=100 Participants
|
94.3 Percentage predicted FEV1
STANDARD_DEVIATION 14.6 • n=100 Participants
|
94.0 Percentage predicted FEV1
STANDARD_DEVIATION 13.8 • n=200 Participants
|
|
Nodule size
|
9.2 mm
STANDARD_DEVIATION 2.7 • n=100 Participants
|
10.1 mm
STANDARD_DEVIATION 3.0 • n=100 Participants
|
9.7 mm
STANDARD_DEVIATION 2.9 • n=200 Participants
|
|
Nodule location
right upper lobe(RUL)
|
26 Participants
n=100 Participants
|
38 Participants
n=100 Participants
|
64 Participants
n=200 Participants
|
|
Nodule location
right middle lobe(RML)
|
9 Participants
n=100 Participants
|
5 Participants
n=100 Participants
|
14 Participants
n=200 Participants
|
|
Nodule location
right lower lobe(RLL)
|
26 Participants
n=100 Participants
|
17 Participants
n=100 Participants
|
43 Participants
n=200 Participants
|
|
Nodule location
left upper lobe(LUL)
|
22 Participants
n=100 Participants
|
25 Participants
n=100 Participants
|
47 Participants
n=200 Participants
|
|
Nodule location
left lower lobe(LLL)
|
17 Participants
n=100 Participants
|
15 Participants
n=100 Participants
|
32 Participants
n=200 Participants
|
|
Nodule type
pure ground glass opacity(GGO)
|
55 Participants
n=100 Participants
|
41 Participants
n=100 Participants
|
96 Participants
n=200 Participants
|
|
Nodule type
Mixed ground glass opacity(GGO)
|
35 Participants
n=100 Participants
|
50 Participants
n=100 Participants
|
85 Participants
n=200 Participants
|
|
Nodule type
Solid
|
10 Participants
n=100 Participants
|
9 Participants
n=100 Participants
|
19 Participants
n=200 Participants
|
|
Distance from pleura
|
6.5 mm
n=100 Participants
|
8.5 mm
n=100 Participants
|
7.8 mm
n=200 Participants
|
PRIMARY outcome
Timeframe: From the time of completing final CT scan, assessed up to 2 days.Population: Modified Intention-to-treat analysis (patients who did not receive lung nodule localization were excluded.(n=10))
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.)
Outcome measures
| Measure |
CT-guided Localization
n=95 Participants
This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
|
Template-guided Localization
n=95 Participants
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: 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.
|
|---|---|---|
|
Accuracy of Lung Nodule Localization
|
9.6 mm
Standard Deviation 5.8
|
8.7 mm
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: From the time of completing final CT scan, assessed up to 1 hour.Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan.
Outcome measures
| Measure |
CT-guided Localization
n=95 Participants
This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
|
Template-guided Localization
n=95 Participants
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: 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.
|
|---|---|---|
|
Procedural Duration of the Nodule Localization
|
9.5 min
Standard Deviation 3.6
|
7.4 min
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: From the time of completing final CT scan, assessed up to 1 hour.Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.
Outcome measures
| Measure |
CT-guided Localization
n=95 Participants
This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
|
Template-guided Localization
n=95 Participants
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: 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.
|
|---|---|---|
|
Radiation Dose
|
313 mGy*cm
Standard Deviation 84
|
229 mGy*cm
Standard Deviation 65
|
SECONDARY outcome
Timeframe: From the time of completing final CT scan, assessed up to 2 days.Pnuemothorax related to lung nodule localization
Outcome measures
| Measure |
CT-guided Localization
n=95 Participants
This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
|
Template-guided Localization
n=95 Participants
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: 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.
|
|---|---|---|
|
Complication Rate
|
17 Participants
|
10 Participants
|
Adverse Events
CT-guided Localization
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Template-guided Localization
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CT-guided Localization
n=95 participants at risk
This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
|
Template-guided Localization
n=95 participants at risk
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: 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.
|
|---|---|---|
|
Surgical and medical procedures
pnueumothorax
|
17.9%
17/95 • Number of events 17 • Adverse event were assessed immediately after lung nodule localization through CT scanning, assessed up to 2 days.
|
10.5%
10/95 • Number of events 10 • Adverse event were assessed immediately after lung nodule localization through CT scanning, assessed up to 2 days.
|
|
Surgical and medical procedures
Hemorrhage
|
11.6%
11/95 • Number of events 11 • Adverse event were assessed immediately after lung nodule localization through CT scanning, assessed up to 2 days.
|
6.3%
6/95 • Number of events 6 • Adverse event were assessed immediately after lung nodule localization through CT scanning, assessed up to 2 days.
|
Additional Information
Dr. Chang Chen
Shanghai Pulmonary Hospital affiliated to Tongji university
Phone: +86 13816869003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place