Evaluation of the Performance and Tolerance of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Patients Suffering From Lung Cancer: Multicenter, Post CE-mark Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 10
- 主要终点
- LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate
研究概览
简要总结
Following CE certification, this Post Market Clinical Follow-up investigates the performance and safety of using the new fiducial marker, NOVATECH® LUCIOLA™ EB, in the lung airways to monitor in real-time tumor location during radiotherapy.
At the time of insertion near the tumor, the Luciola's 3 fiducial marker arms are deployed simultaneously. Optimal detection of the fiducial marker is considered during the radiotherapy treatment.
详细描述
NOVATECH® LUCIOLA™ EB fiducial marker will be implanted near the lung tumor by bronchial endoscopy by a pulmonologist. Following a dosimetry visit, participants will be proposed a maximum of 5 radiation therapy sessions. A follow-up visit at 3 months will take place after the last radiotherapy session. The participation period for each participant will be between 4.5 and 6 months. This study will evaluate the Luciola implant's performance and safety (visibility, migration, complications, tumoral response).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 18 years of age
- •Participants with primary, secondary or metastatic lung cancer with an indication for radiotherapy and placement of a fiducial marker
- •Participants who will be able to tolerate the flexible bronchoscopic implantation procedure and radiotherapy treatment.
- •Participants who give their written informed consent
排除标准
- •Participants with uncontrolled infection / participants with active infections.
- •Participants with a bronchoscopy contra-indication
- •Pregnant or breast-feeding women
- •Participants with known allergy to one of the components (tantalum and nickel titanium alloy for the marker and polymer materials which are contained in the delivery device)
结局指标
主要结局
LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate
时间窗: Takes place 4-6 weeks after implantation
Number of RT sessions during which the LUCIOLA implant was used for treatment in relation to the total number of RT sessions. If LUCIOLA can be detected and used for treatment, the patient will attend 3 to 5 RT sessions over a period lasting 1 to 2 weeks.
次要结局
- Pulmonologist's satisfaction(Within 24 hours after implantation)
- Luciola implant "visibility"(From the dosimetry visit (week 2-4 after implantation) to the last RT session (3-4 weeks after dosimetry))
- Adverse events(4.5 to 6 months (from implantation to the end of participant's enrollment in the study))
- Replanning radiotherapy treatment(During radiotherapy sessions (4-6 weeks after implantation))
- Radiotherapist's satisfaction(End of study visit: 12 weeks after last radiotherapy session)
- Tumoral response(Between the inclusion CT-Scan (8 weeks prior to implantation at the most) and the radiotherapy end of treatment CT-Scan (12 weeks after last RT session))
- Global migration rate(Dosimetry CT-Scan takes place 2-4 weeks after implantation; End of treatment CT-Scan takes place 12 weeks after last radiotherapy session)
研究者
ESCARGUEL Bruno
Pulmonologist
Hospital St. Joseph, Marseille, France