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

January 8, 2021 updated by: Rafael DURAN, MD, Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, 1011
        • Recruiting
        • Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with lung cancer (1ary and 2ndary), not eligible for surgery, and treated by radiation therapy needing a fiducial marker placement will be eligible for this study which is a prospective randomized controlled trial (endovascular vs endobronchic fiducial marker).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Endovascular fiducial marker insertion
Fiducial markers will be inserted using an endovascular route
Bronchoscopic fiducial marker insertion
Fiducial markers are inserted and released near the tumor into the bronchi using an endoscopic route
Procedure: Bronchoscopic fiducial marker insertion
Fiducial markers will be inserted using an endoscopic route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cyberknife© tracking
Time Frame: Before Cyberknife
Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation
Before Cyberknife

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fiducial implantation evaluation by operator
Time Frame: Immediately post-implantation
Assessment of technical feasibility of implantation of at least three fiducial markers around the lung tumor in both techniques
Immediately post-implantation
Fiducial marker migration
Time Frame: Immediately post-implantation and before Cyberknife
Secondary fiducial migration rate assessment in both techniques
Immediately post-implantation and before Cyberknife
Procedure time
Time Frame: Immediately after the procedure
Procedure time required for the implantation of three markers around the lung tumor in both techniques
Immediately after the procedure
Complication rate
Time Frame: within 30 days of fiducial marker placement
Complication rate (AE/SEA) within 30 days of fiducial marker placement in both techniques
within 30 days of fiducial marker placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2016

Primary Completion (ANTICIPATED)

June 1, 2025

Study Completion (ANTICIPATED)

June 1, 2026

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (ACTUAL)

December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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