RecruitingNCT04684186

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

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


Sponsor

Centre Hospitalier Universitaire Vaudois

Enrollment

60 participants

Start Date

Oct 10, 2016

Study Type

OBSERVATIONAL

Conditions

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 (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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two ways of placing small markers (called fiducial markers) inside a lung tumor so that a radiation machine can precisely track and target the tumor in real time during treatment. One approach goes through the bloodstream (endovascular), the other goes through the airway (bronchoscopic). **You may be eligible if...** - You are between 18 and 85 years old - You have lung cancer — either primary (started in the lung) or secondary (spread to the lung from elsewhere) - You are scheduled to receive stereotactic radiotherapy (a highly precise form of radiation) - You have signed consent to participate **You may NOT be eligible if...** - You are under 18 or over 85 - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndovascular fiducial marker insertion

Fiducial markers will be inserted using an endovascular route

PROCEDUREBronchoscopic fiducial marker insertion

Fiducial markers will be inserted using an endoscopic route


Locations(1)

Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology

Lausanne, Canton of Vaud, Switzerland

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NCT04684186


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