NCT04684186

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

Recruiting now Last updated 12 January 2021

What this trial tests

trial testing Endovascular fiducial marker insertion in Lung Cancer in 60 participants. Currently enrolling.

Timeline

10 October 2016

Primary endpoint
1 June 2025

1 June 2026

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Vaudois
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	60
Start date	10 October 2016
Primary completion	1 June 2025
Estimated completion	1 June 2026
Sites	1 location across Switzerland

Drugs / interventions tested

• Endovascular fiducial marker insertion
• Bronchoscopic fiducial marker insertion

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →
• Lung Metastases — all drugs for Lung Metastases →
• Radiotherapy — all drugs for Radiotherapy →

Sponsor

Centre Hospitalier Universitaire Vaudois

Who can join

18 and older, any sex, with Lung Cancer or Lung Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Fiducial markers for stereotactic lung radiation therapy: review of the transthoracic, endovascular and endobronchial approaches.
   Casutt A, Kinj R, Ozsahin EM, von Garnier C, et al · · 2022 · cited 13× · PMID 35022258 · DOI 10.1183/16000617.0149-2021