Lung Cancer, Lung Metastases, Radiotherapy
Conditions
Keywords
fiducial marker placement, stereotactic body radiotherapy, interventional radiology
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 (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.
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
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cyberknife© tracking | Before Cyberknife | Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fiducial implantation evaluation by operator | Immediately post-implantation | Assessment of technical feasibility of implantation of at least three fiducial markers around the lung tumor in both techniques |
| Fiducial marker migration | Immediately post-implantation and before Cyberknife | Secondary fiducial migration rate assessment in both techniques |
| Procedure time | Immediately after the procedure | Procedure time required for the implantation of three markers around the lung tumor in both techniques |
| Complication rate | within 30 days of fiducial marker placement | Complication rate (AE/SEA) within 30 days of fiducial marker placement in both techniques |
Countries
Switzerland
Contacts
Primary ContactRafael DURAN, MD
Outcome results
None listed