Comparison Between Endovascular and Bronchoscopic Tumor Marker Insertion for Real-time Stereotactic-guided Radiotherapy in Lung Cancer

Study Overview
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Brief Summary
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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 (2)(3). 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© (4)(5)(6)(7)(8). 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 (9)(10)(11) (12), endovascular (12)(13) fiducial implantation or by means of bronchoscopic devices (14)(15)(16)(17)(18) 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 (19)(20). 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 (21)(22). 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.

Official Title
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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

Conditions
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Lung Cancer, Lung Metastases, Radiotherapy

Intervention / Treatment
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* Procedure: Endovascular fiducial marker insertion
* Procedure: Bronchoscopic fiducial marker insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lung cancer (primary or secondary, any histological type) Early stage lung cancer: patients diagnosed with stage I for which operation is contra-indicated, for example because of cardiac or pulmonary comorbidities. Locally advanced lung cancer stages II - IIIB Metastatic lung cancer stage IV (palliative care) 18 y ≤ age ≤ 85 y Exclusion Criteria: age <18y incapacity of judgment Absence of a signed consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular fiducial marker insertion<br>Fiducial markers are inserted and released near the tumor through femoral puncture. A catheter is led through the venous system to the right heart and from there through the heart into the pulmonary arteries. | Procedure: Endovascular fiducial marker insertion<br>* Fiducial markers will be inserted using an endovascular route<br>|
| Bronchoscopic fiducial marker insertion<br>Fiducial markers are inserted and released near the tumor into the bronchi using an endoscopic route | Procedure: Bronchoscopic fiducial marker insertion<br>* Fiducial markers will be inserted using an endoscopic route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cyberknife© tracking | Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation | Before Cyberknife | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fiducial implantation evaluation by operator | Assessment of technical feasibility of implantation of at least three fiducial markers around the lung tumor in both techniques | Immediately post-implantation | 
| Fiducial marker migration | Secondary fiducial migration rate assessment in both techniques | Immediately post-implantation and before Cyberknife | 
| Procedure time | Procedure time required for the implantation of three markers around the lung tumor in both techniques | Immediately after the procedure | 
| Complication rate | Complication rate (AE/SEA) within 30 days of fiducial marker placement in both techniques | within 30 days of fiducial marker placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fiducial marker placement, stereotactic body radiotherapy, interventional radiology