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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2026
  • participants needed
    60
  • sponsor
    Centre Hospitalier Universitaire Vaudois
Updated on 2 February 2021

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.

Details
Condition Pulmonary Disease, Lung Disease, Radiation Oncology, Radiotherapy, radiotherapeutic, Lung Neoplasm, Lung Cancer, Bronchial Neoplasm, Lung Metastasis, Lung Metastases, Lung Cancer, Lung Disease, Pulmonary Metastasis, carcinoma lung, lung carcinoma
Treatment Endovascular fiducial marker insertion, Bronchoscopic fiducial marker insertion
Clinical Study IdentifierNCT04684186
SponsorCentre Hospitalier Universitaire Vaudois
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

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)
y age 85 y

Exclusion Criteria

age <18y
incapacity of judgment
Absence of a signed consent form
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