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

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ClinicalTrials.gov Identifier: NCT04684186
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Rafael DURAN, MD, 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.


Condition or disease Intervention/treatment
Lung Cancer Lung Metastases Radiotherapy Procedure: Endovascular fiducial marker insertion Procedure: Bronchoscopic fiducial marker insertion

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : October 10, 2016
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




Primary Outcome Measures :
  1. Cyberknife© tracking [ Time Frame: Before Cyberknife ]
    Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation


Secondary Outcome Measures :
  1. 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

  2. Fiducial marker migration [ Time Frame: Immediately post-implantation and before Cyberknife ]
    Secondary fiducial migration rate assessment in both techniques

  3. Procedure time [ Time Frame: Immediately after the procedure ]
    Procedure time required for the implantation of three markers around the lung tumor in both techniques

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684186


Contacts
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Contact: Rafael DURAN, MD +41213144444 rafael.duran@chuv.ch

Locations
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Switzerland
Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology Recruiting
Lausanne, VD, Switzerland, 1011
Contact: Rafael DURAN    +41213144444    rafael.duran@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Publications of Results:
Other Publications:

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Responsible Party: Rafael DURAN, MD, M.D., Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04684186    
Other Study ID Numbers: 2016-00046
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021

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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
Keywords provided by Rafael DURAN, MD, Centre Hospitalier Universitaire Vaudois:
fiducial marker placement
stereotactic body radiotherapy
interventional radiology
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases