跳至主要内容
临床试验/NCT04684186
NCT04684186招募中不适用

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

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Cyberknife© tracking

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Cyberknife© tracking

时间窗: Before Cyberknife

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rafael DURAN, MD

M.D.

Centre Hospitalier Universitaire Vaudois

研究点 (1)

Loading locations...

相似试验

Comparison Between Endovascular and Bronchoscopic... | 临床试验