Clinical trial · Observational
Comparison Between Endovascular and Bronchoscopic Tumor Marker Insertion for Real-time Stereotactic-guided Radiotherapy in Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Metastases | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bronchoscopic fiducial marker insertion | Procedure | — | UNRESOLVED |
| Endovascular fiducial marker insertion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Endovascular fiducial marker insertion
- description
- 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.
- interventionNames
- Procedure: Endovascular fiducial marker insertion
- label
- Bronchoscopic fiducial marker insertion
- description
- Fiducial markers are inserted and released near the tumor into the bronchi using an endoscopic route
- interventionNames
- Procedure: Bronchoscopic fiducial marker insertion
Primary outcomes (1)
- measure
- Cyberknife© tracking
- timeFrame
- Before Cyberknife
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (22)
- BACKGROUNDHagmeyer L, Priegnitz C, Kocher M, Schilcher B, Budach W, Treml M, Stieglitz S, Randerath W. Fiducial marker placement via conventional or electromagnetic navigation bronchoscopy (ENB): an interdisciplinary approach to the curative management of lung cancer. Clin Respir J. 2016 May;10(3):291-7. doi: 10.1111/crj.12214. Epub 2014 Nov 3. PMID 25308297
- BACKGROUNDHarada T, Shirato H, Ogura S, Oizumi S, Yamazaki K, Shimizu S, Onimaru R, Miyasaka K, Nishimura M, Dosaka-Akita H. Real-time tumor-tracking radiation therapy for lung carcinoma by the aid of insertion of a gold marker using bronchofiberscopy. Cancer. 2002 Oct 15;95(8):1720-7. doi: 10.1002/cncr.10856. PMID 12365020
- BACKGROUNDSiegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin. 2011 Jul-Aug;61(4):212-36. doi: 10.3322/caac.20121. Epub 2011 Jun 17. PMID 21685461
- BACKGROUNDFerlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26. PMID 23485231
- BACKGROUNDDetterbeck FC, Lewis SZ, Diekemper R, Addrizzo-Harris D, Alberts WM. Executive Summary: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):7S-37S. doi: 10.1378/chest.12-2377. No abstract available. PMID 23649434
- BACKGROUNDDetterbeck FC. Lobectomy versus limited resection in T1N0 lung cancer. Ann Thorac Surg. 2013 Aug;96(2):742-4. doi: 10.1016/j.athoracsur.2013.03.074. No abstract available. PMID 23910135
- BACKGROUNDStefani A, Nesci J, Casali C, Morandi U. Wedge resection versus lobectomy for T1N0 non-small cell lung cancer. Minerva Chir. 2012 Dec;67(6):489-98.