Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 10
- 主要终点
- To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.
研究概览
简要总结
Clinical study investigating the feasibility and safety of using an anchored Calypso transponder in the airways of the lung for real-time monitoring of tumor location during radiotherapy
详细描述
The Calypso anchored lung transponders are a modified version of the previously FDA-cleared Calypso soft tissue transponders. This modification includes an anchoring mechanism to hold the transponder positionally stable within small airways of the lung. Transponders are placed locally to the tumor within the lung and during subsequent radiotherapy the Calypso system may be used to monitor the location of the transponders and, by extension, the tumor, in real-time. This allows for improved tumor-targeting as well as gating of the radiation beam when the tumor moves outside the target field during respiratory motion.
The goals of this investigation are to show that patients with implanted anchored transponders can be localized with the Calypso System, that anchored transponder implantation and use are feasible and safe, and that anchored transponders are positionally stable in the small airways of patients with cancer of the lung.
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
- •Age ≥ 18 years at time of consent (19 years if required by local or state laws)
- •Patients planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or cancer that is metastatic to the lung.
- •Patients who are to receive 30 Gy or more of external beam radiation therapy.
- •Patients who are able to tolerate flexible bronchoscopy.
- •Patients with life expectancy of at least 12 months and who are expected to be able to complete the full follow-up assessment in the protocol.
- •Patients for whom the physician is able to identify suitable implantation sites for the anchored transponders on a recent (within the past 8 weeks) CT scan. This will require acquisition of a CT scan if a suitable one is not already available.
- •Patients who are able to comply with the protocol.
排除标准
- •Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which the Sponsor considers will interfere with the Calypso System's electromagnetic localization (note that the Sponsor will review a patient's implanted metal on a case by case basis).
- •Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effect of the Calypso System operation on these devices is unknown.
- •Patients with active infections.
- •Patients with bronchiectasis in the lobe of the intended implantation sites.
- •Patients with a history of hypersensitivity to nickel.
- •Patients whose lung tumors are being monitored with MR imaging (MR imaging of the anchored transponders is safe but yields an image artifact around the anchored transponders).
- •Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
- •Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
研究组 & 干预措施
Transponder implantation
Implantation of anchored Beacon transponder in the lung
干预措施: Implantation of anchored Beacon transponder in the lung (Device)
结局指标
主要结局
To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.
时间窗: 1-2 weeks following implantation
Whether a patient can be localized by the Calypso System using the anchored transponders will be determined during the first week (i.e., the first five fractions) of radiation therapy.
次要结局
- To Assess the Positional Stability of the Anchored Transponders Short Term Through the Completion of Radiotherapy and Long Term Through One Year of Follow-up.(1-14 months, depending on the duration of radiotherapy and time between follow-up visits.)
- To Assess the Implantation Procedure of the Anchored Transponder in the Lung(1-2 weeks following implantation)
- To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume(1-2 weeks following implantation)
- To Collect Target Localization and Tracking Data With the Calypso System During Radiation Treatment Sessions(Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks)
- To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data During the Radiation Treatment Sessions(Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks)
- To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure(Time of implantation through the completion of the follow-up period of the study (0-14 months))