Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04684186
Status:
RECRUITING
Last Update Posted:
2021-01-12
First Post:
2020-12-07
Brief Title:
Comparison Between Endovascular and Bronchoscopic Tumor Marker Insertion for Real-time Stereotactic-guided Radiotherapy in Lung Cancer
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Real-time Guided Stereotactic Radiotherapy in Lung Cancer Using Endovascular Coils for Tumor Marking Head-to-head Comparison Between Endovascular and Bronchoscopic Fiducial Marker Insertion
Status:
RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The role of radiotherapy is well established in the management of early stage lung cancer or as part of a multidisciplinary approach of locally advanced lung cancer 1
Recent advances in Cyberknife technology which is a robotic system of stereotactic irradiation including localisation and real time lesion-tracking has led to an increase in accuracy and potentially in efficiency of the irradiation of tumor field 23 According to several studies promising results in local control and survival rates have been achieved in patients suffering from primary lung cancer or peripheral lung metastasis treated with Cyberknife 45678
Fiducial markers are implanted in or near a tumor in a configuration defining a COM center of mass guiding the Cyberknife for tumor localization
Tumor movement is then synchronized to respiratory cycle motion during treatment which reduces toxicity of non target lung tissue irradiation Change in marker positioning leads to COM alterations thus limiting detection by the tracking system
Percutaneous 91011 12 endovascular 1213 fiducial implantation or by means of bronchoscopic devices 1415161718 are three techniques that have been validated in previous studies as feasible and safe procedures providing accurate tracking
Few studies are currently available in the litterature comparing these modalities 1920 The percutaneous implantation technique will not be considered for this study because this technique is associated with a high risk of pneumothorax 9
Both the endobronchial and endovascular technique have been described in the literature with equivalent success rate 87-90 in intention to treat 2122
One of the endpoints of this study is to verify that these results are reproducible in our institution where both techniques are currently available and to investigate other secondary endpoints such as fiducial marker migration after placement complications rates and procedure time
Recent advances in Cyberknife technology which is a robotic system of stereotactic irradiation including localisation and real time lesion-tracking has led to an increase in accuracy and potentially in efficiency of the irradiation of tumor field 23 According to several studies promising results in local control and survival rates have been achieved in patients suffering from primary lung cancer or peripheral lung metastasis treated with Cyberknife 45678
Fiducial markers are implanted in or near a tumor in a configuration defining a COM center of mass guiding the Cyberknife for tumor localization
Tumor movement is then synchronized to respiratory cycle motion during treatment which reduces toxicity of non target lung tissue irradiation Change in marker positioning leads to COM alterations thus limiting detection by the tracking system
Percutaneous 91011 12 endovascular 1213 fiducial implantation or by means of bronchoscopic devices 1415161718 are three techniques that have been validated in previous studies as feasible and safe procedures providing accurate tracking
Few studies are currently available in the litterature comparing these modalities 1920 The percutaneous implantation technique will not be considered for this study because this technique is associated with a high risk of pneumothorax 9
Both the endobronchial and endovascular technique have been described in the literature with equivalent success rate 87-90 in intention to treat 2122
One of the endpoints of this study is to verify that these results are reproducible in our institution where both techniques are currently available and to investigate other secondary endpoints such as fiducial marker migration after placement complications rates and procedure time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None