Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer

CivaTech Oncology的使命是直接向本地化患者提供改进的放射治疗 肿瘤。该公司开发了一种新型的、聚合物封装的膜状放射源 它只在设备的一侧--CivaSheet--发出辐射。此定向信号源是兼容的 具有开放和微创手术技术，并已获得FDA批准，可用作主要或 癌症综合疗法。CivaSheet是一种可部分生物吸收的植入物，可应用于 初次手术的时间。Civa Sheet缩短了手术和放射治疗之间的时间， 这对病人是有好处的。此外，CivaSheet还可以在照射时保护健康组织 病变组织或肿瘤边缘。这种屏蔽使CivaSheet能够在近距离植入 对辐射敏感的结构而不过量--这是胸癌的一个潜在优势。 在第一阶段，CivaTech肿瘤科将确认CivaSheet在植入后不会移动，并且 这种出色的剂量学是可以实现的。Civa Sheet将在肺叶内植入 分割或楔形切除--肺癌患者的标准护理程序 忍受肺叶完全切除。CivaSheet将通过在 首次手术的时间，以最大限度地减少治疗延误。对于肺癌患者，完全切除肺叶 对于能耐受它的患者是首选。对于那些做不到的人来说，对手术边缘的辐射是一种 潜在的好处。在第一阶段，CivaSheet的安全性和在本阶段中使用的一般建议 患者人数将被评估。对外科植入技术的变化也将进行评估。 第二阶段将包括两个同时进行的临床试验，探索CivaSheet AS的使用 加强肺癌患者的放射治疗。人工血管植入术后局部复发率的研究 CivaSheet将与目前20%的税率进行比较。此外，生活质量、疼痛和 将对每名患者的死亡率进行监测。Civa Sheet将减少向邻近地区传递的辐射 纵隔给药，因此副作用应该更少。此外，它还将提供保形 剂量，降低感染风险，并可能减少与治疗相关的副作用。 CivaSheet是一种真正独特的近距离放射治疗设备，有可能成为第一线 对局部癌症的防御。CivaTech Oncology致力于将CivaSheet提供给 多种适应症的癌症患者。

CivaTech Oncology’s mission is to provide improved radiation therapy directly to localized tumors. The Company has developed a novel, polymer-encapsulated, membrane-like radiation source that emits radiation on only one side of the device – the CivaSheet. This directional source is compatible with open and minimally invasive surgical techniques and has FDA clearance to be used as primary or combined cancer therapy. The CivaSheet is a partially bio-absorbable implant that can be applied at the time of the initial surgery. The CivaSheet decreases the time between surgery and radiation therapy, which is a benefit to the patient. Additionally, the CivaSheet can shield healthy tissues while irradiating the diseased tissue or tumor margin. This shielding enables the CivaSheet to be implanted close to radiosensitive structures without overdosing them – a potential advantage for cancers in the thorax. In Phase I, CivaTech Oncology will confirm the CivaSheet does not move after implantation and that excellent dosimetry can be achieved. The CivaSheet will be implanted during lung lobe segmentation or wedge resection – a standard of care procedure for lung cancer patients who cannot tolerate full lobectomy. The CivaSheet will benefit these patients by delivering radiation therapy at the time of initial surgery to minimize delay in the treatment. For lung cancer patients complete lobectomy is preferred for patients who can tolerate it. For those who cannot, radiation to the surgical margin is a potential benefit. In Phase I, the safety of CivaSheet and general recommendations for its use in this patient population will be assessed. Changes to the surgical implant technique will be assessed as well. The Phase II will consist of two concurrent clinical trials exploring the use of the CivaSheet as boost radiation therapy in lung cancer patients. The rate of local recurrence in patients implanted with CivaSheet will be compared to the current rate of 20%. Additionally, the quality of life, pain, and mortality in each patient will be monitored. CivaSheet will reduce the radiation delivered to adjacent mediastinum and therefore should result in fewer side effects. Additionally, it will provide a conformal dose, reduce the risk for infection, and possibly reduce treatment related side effects. CivaSheet is a truly unique brachytherapy device that has the potential to become the first line of defense for localized cancer. CivaTech Oncology is committed to making the CivaSheet available to cancer patients in multiple indications.