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

Recruiting

• Conditions: Lung Cancer; Radiotherapy; Lung Metastases
• Interventions: Procedure: Bronchoscopic fiducial marker insertion; Procedure: Endovascular fiducial marker insertion

• Registration Number: NCT04684186
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-10
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchoscopic fiducial marker insertion	Bronchoscopic fiducial marker insertion	Fiducial markers are inserted and released near the tumor into the bronchi using an endoscopic route
Endovascular fiducial marker insertion	Endovascular fiducial marker insertion	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.

Primary Outcome Measures

Name	Time	Method
Cyberknife© tracking	Before Cyberknife	Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology; 🇨🇭 Lausanne, VD, Switzerland