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Trial Title:
From Benchmark to Surgical Activity: the Role of Endobronchial Fiducial Markers for Ground Glass Lung Nodules Resection.
NCT ID:
NCT05801406
Condition:
Lung Cancer
Lung Non-Small Cell Carcinoma
Lung; Node
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Ultrasound
Marker
Fluoroscopy
Lung
Cancer
Bronchoscopy
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Tornado (Cook)
Description:
Fiducial marker endobronchial positioning under augmented fluoroscopy to mark ground
glass opacities.
Summary:
With the risen popularity of low-dose computed tomography (LDCT) for lung cancer
screening, many patients present with peripheral pulmonary ground-glass nodules (GGNs)
with a suspicious solid part. The appropriate diagnostic and management strategy for
those lesions can be questionable. If malignancy is suspected, a surgical biopsy with the
guidance of various localization methods available is recommended.
Each localization method has its advantages and disadvantages. Therefore, it may not be
possible to establish a gold standard for localizing indeterminate lung nodules since
comparative clinical trials are lacking.
Detailed description:
The management of pulmonary ground-glass nodules (GGNs) may be different. If GGN is an
incidental finding through LDCT, the lesion should be followed according to the current
guidelines. It is recommend a multidisciplinary team discussion to be initiated if a new
solid component develops or the solid portion size grows on follow-up CT as the risk of
malignancy is high. Attempts to preoperatively biopsy solid components in part-solid GGNs
are often not feasible and not helpful in clinical settings. Currently, if malignancy is
suspected, a surgical biopsy with the guidance of various localization methods is
recommended. If malignancy is confirmed, sub-lobar resection may provide an excellent
oncologic outcome.
The LungVision system is a novel augmented-fluoroscopy-based real-time navigation and
guidance technology for bronchoscopy that can enable real-time visualization and
localization of pulmonary nodules.
In this study, all patients over the age of 18 will be enrolled in case of finding of
lung GGNs with the presence of a solid part inside> = 6 mm or with a solid part even less
than 6 mm but with an increase in size. These must be subject to surgical treatment for
both diagnostic or therapeutic purposes. These nodules must have a bronchus sign inside.
In these patients, a bronchoscopy under general anesthesia with oro-tracheal intubation
with LungVision system and r-EBUS will be performed to select the area to mark with
fiducial marker. After fiducial marker placement, a CT scan will be performed to control
the position of fiducial marker compared to the lesion. Patients will subsequently
undergo surgical treatment by using intraoperative ultrasonography to detect the position
of fiducial marker in the completely deflated lung. The correct positioning of the
fiducial marker compared to the lesion and the complete surgical excision of the target
lesion will be evaluated on the surgical specimen.
Criteria for eligibility:
Study pop:
In this study, all patients over the age of 18 will be selected in case of finding of
lung GGNs with the presence of a solid part inside > = 6 mm or with a solid part even
less than 6 mm but with an increase in size. These must be subject to surgical treatment
for both diagnostic or therapeutic purposes.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- all patients over the age of 18;
- lung GGNs with the presence of a solid part inside > = 6 mm or with a solid part
even less than 6 mm but with an increase in size;
- subjects evaluated for surgical treatment during multidisciplinary tumor board.
Exclusion Criteria:
- Patients not eligible for surgery
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gian Piero Bandelli
Address:
City:
Bologna
Zip:
40133
Country:
Italy
Contact:
Last name:
Gian Piero Bandelli, MD
Phone:
+390512149121
Email:
gianpiero.bandelli@aosp.bo.it
Contact backup:
Last name:
Niccolò Daddi, MD, PhD
Phone:
+390512149049
Email:
niccolo.daddi@unibo.it
Start date:
October 1, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Agency class:
Other
Source:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05801406