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

新型单向 Pd-103 CivaSheet 用于肺癌的临床评估

• 批准号: 10250609
• 负责人: Kristy Perez
• 金额: $ 0.06万
• 依托单位: CIVATECH ONCOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-13 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10250609
• 关键词: Absorbable Implants; Acute; Applications Grants; Brachytherapy; Cancer Patient; Chest; Chest wall structure; Clinical; Clinical Trials; Data; Devices; Disease; Dose; Dose-Limiting; Effectiveness; Encapsulated; Excision; External Beam Radiation Therapy; Gold; Grant; Heart; Implant; Injury; Institution; Instruction; Lobe; Lobectomy; Localized Malignant Neoplasm; Location; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Mediastinum; Membrane; Methods; Mission; Monitor; Movement; National Comprehensive Cancer Network; New York City; Oncology; Operative Surgical Procedures; Organ; Outcome; Overdose; Pain; Palladium 103; Patients; Phase; Polymers; Positioning Attribute; Procedures; Protocols documentation; Quality of life; Radiation; Radiation Dose Unit; Radiation Oncologist; Radiation Tolerance; Radiation therapy; Readiness; Recommendation; Recurrence; Reporting; Research Personnel; Resected; Risk; Safety; Side; Site; Source; Statistical Data Interpretation; Structure; Surgeon; Surgical margins; Techniques; Testing; Therapeutic Effect; Time; TimeLine; Tissues; Toxic effect; Training; Tumor Tissue; Vertebral column; Work; X-Ray Computed Tomography; appropriate dose; arm; cancer therapy; clinical research site; cohort; cost effective; dosimetry; follow-up; implantable device; implantation; improved; in vivo; infection risk; lung lobe; minimally invasive; mortality; novel; patient population; primary endpoint; recruit; research clinical testing; side effect; standard of care; tumor

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.

CivaTech Oncology的使命是直接为局部患者提供改进的放射治疗。 肿瘤的该公司开发了一种新型的聚合物封装膜状辐射源 它只在设备的一面--CivaSheet上发射辐射。这个定向源兼容 采用开放和微创手术技术，并获得FDA许可，可用作主要或 联合癌症治疗CivaSheet是一种部分生物可吸收的植入物，可应用于 第一次手术的时间CivaSheet缩短了手术和放射治疗之间的时间， 这对患者是有益的。此外，CivaSheet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能够植入靠近 放射敏感的结构，而不会过量-一个潜在的优势，在胸部癌症。 在I期，CivaTech Oncology将确认CivaSheet在植入后不会移动， 可以实现极好的剂量测定。CivaSheet将在肺叶期间植入 分割或楔形切除术- 能忍受全肺叶切除术CivaSheet将通过在放射治疗中心提供放射治疗而使这些患者受益。 首次手术的时间，以尽量减少治疗的延迟。对于肺癌患者完整肺叶切除术 对于那些不能耐受的患者，手术切缘的放射治疗是一种有效的治疗方法。 潜在的好处。在第一阶段，CivaSheet的安全性及其在这方面的一般建议 将对患者人群进行评估。还将评估手术植入技术的变更。 第二阶段将包括两个同时进行的临床试验，探索使用CivaSheet作为 肺癌患者的放射治疗。患者植入的局部复发率 CivaSheet将与目前的20%利率进行比较。此外，生活质量、疼痛和 将监测每名患者的死亡率。CivaSheet将减少辐射传递到邻近的 纵隔，因此应导致较少的副作用。此外，它还将提供一个保形 剂量，降低感染的风险，并可能减少治疗相关的副作用。 CivaSheet是一款真正独特的近距离放射治疗设备，有可能成为一线 局部癌症的防御机制。CivaTech Oncology致力于将CivaSheet提供给 多种适应症的癌症患者。