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

NCT04684186 | Recruiting

• 1 other identifier: 2016-00046
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Lung Metastases; Radiotherapy

Keywords

fiducial marker placement; stereotactic body radiotherapy; interventional radiology

Outcome Measures

Primary Outcomes (1)

• Cyberknife© tracking

  Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation

  Before Cyberknife

Secondary Outcomes (4)

• Fiducial implantation evaluation by operator

  Immediately post-implantation

• Fiducial marker migration

  Immediately post-implantation and before Cyberknife

• Procedure time

  Immediately after the procedure

• Complication rate

  within 30 days of fiducial marker placement

Study Arms (2)

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

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

Interventions

Endovascular fiducial marker insertion PROCEDURE

Fiducial markers will be inserted using an endovascular route

Endovascular fiducial marker insertion

Bronchoscopic fiducial marker insertion PROCEDURE

Fiducial markers will be inserted using an endoscopic route

Bronchoscopic fiducial marker insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (22)

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  PMID: 12365020 BACKGROUND

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  PMID: 23334112 BACKGROUND

• Ahn SH, Han MS, Yoon JH, Jeon SY, Kim CH, Yoo HJ, Lee JC. Treatment of stage I non-small cell lung cancer with CyberKnife, image-guided robotic stereotactic radiosurgery. Oncol Rep. 2009 Mar;21(3):693-6.

  PMID: 19212628 BACKGROUND

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  PMID: 21349655 BACKGROUND

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• Boschini FJ, Commander CW, Schreiber EC, Yu H, Dixon RG. Comparison of Gold Seeds, Tight Embolization Coils, and Loose Embolization Coils Used as Fiducial Markers for Dynamic Tracking Using CyberKnife. Pract Radiat Oncol. 2013 Apr-Jun;3(2 Suppl 1):S22. doi: 10.1016/j.prro.2013.01.074. Epub 2013 Mar 25. No abstract available.

  PMID: 24674518 BACKGROUND

• Nuyttens JJ, Prevost JB, Praag J, Hoogeman M, Van Klaveren RJ, Levendag PC, Pattynama PM. Lung tumor tracking during stereotactic radiotherapy treatment with the CyberKnife: Marker placement and early results. Acta Oncol. 2006;45(7):961-5. doi: 10.1080/02841860600902205.

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• Schroeder C, Hejal R, Linden PA. Coil spring fiducial markers placed safely using navigation bronchoscopy in inoperable patients allows accurate delivery of CyberKnife stereotactic radiosurgery. J Thorac Cardiovasc Surg. 2010 Nov;140(5):1137-42. doi: 10.1016/j.jtcvs.2010.07.085. Epub 2010 Sep 20.

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  PMID: 20675070 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Rafael DURAN, MD

CONTACT

+41213144444; rafael.duran@chuv.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 24, 2020
• Study Start: October 10, 2016
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

CH (1)