Administrative Supplement for the Evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer

用于评估新型单向 Pd-103 CivaSheet 治疗肺癌的行政补充

• 批准号: 10310817
• 负责人: Kristy Perez
• 金额: $ 22.04万
• 依托单位: CIVATECH ONCOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-16 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10310817
• 关键词: Absorbable Implants; Acute; Administrative Supplement; Award; Brachytherapy; Budgets; Cancer Patient; Case Study; Clinical Trials; Devices; Disease; Dose; Encapsulated; Evaluation; Excision; Funding; Heart; Implant; Localized Malignant Neoplasm; Malignant Neoplasms; Malignant neoplasm of lung; Mediastinum; Membrane; Mission; Monitor; Myocardium; Oncology; Operative Surgical Procedures; Overdose; Palladium 103; Parents; Pathway interactions; Patients; Polymers; Privatization; Production; Radiation; Radiation Dose Unit; Radiation Tolerance; Radiation Toxicity; Radiation therapy; Recommendation; Recurrence; Reporting; Safety; Side; Small Business Innovation Research Grant; Source; Structure; Techniques; Time; Tissues; Toxic effect; Work; cancer therapy; implantation; improved; minimally invasive; novel; parent grant; radiation delivery; research clinical testing; side effect; tumor

Parent Award: R44CA217587 Clinical Evaluation of the novel, Uni-directional Pd-103 CivaSheet for Lung Cancers 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 – 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. CivaSheet is a bio-absorbable implant that can be applied at the time of the initial surgery. CivaSheet decreases the time between surgery and radiation therapy, which is a benefit to the patient. Additionally, CivaSheet can shield healthy tissues while irradiating the diseased tissue or tumor margin. This shielding enables CivaSheet to be implanted close to radiosensitive structures without overdosing them – a huge advantage for cancers near the heart and mediastinum. CivaTech Oncology has confirmed in case studies, that CivaSheet does not move after implantation and that a substantial and beneficial dose can be delivered for lung cancer patients. CivaSheet greatly benefits these patients by delivering localized radiation therapy at the time of initial surgery to protect against local recurrence, a significant concern for lung cancer patients. Over the course of the SBIR Fast Track Parent Grant, the safety of CivaSheet in lung cancer patients was demonstrated and general surgical recommendations for its use were defined. Additionally, the SBIR Fast Track Parent Grant (R44CA217587) supports a clinical trial to implant CivaSheet during sublobar resection of lung cancer patients. The rate of local recurrence in patients implanted with CivaSheet is being evaluated and compared to the historical rate of 20%. The acute radiation toxicity is also monitored as part of the study. CivaSheet delivers substantially less radiation to adjacent mediastinum and heart muscle compared to other forms of radiation delivery and no device related toxicity has been reported. This Administrative Supplement is requested to provide budget for the production and supply of CivaSheets for clinical trial use. The SBIR Fast Track Parent Grant budget assumed CivaSheet would be reimbursed through CMS and private payors. CivaSheet is not reimbursed and it is greatly impacting the ability to complete this proposed work and provide access to patients. With this Administrative Supplement, CivaTech Oncology will be able to more quickly complete the clinical trials. 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 CivaSheet available to cancer patients in multiple indications.

家长奖：R44CA217587 新型单向 Pd-103 CivaSheet 用于肺癌的临床评估 CivaTech Oncology 的使命是直接为局部肿瘤提供改进的放射治疗。公司拥有 开发了一种新型聚合物封装的膜状辐射源，仅在一侧发射辐射 设备 – CivaSheet®。该定向源与开放式微创手术技术兼容，并且具有 FDA 批准用作主要或联合癌症治疗。 CivaSheet 是一种生物可吸收植入物 在初次手术时应用。 CivaSheet 缩短了手术和放射治疗之间的时间， 对患者有好处。此外，CivaSheet 可以在照射患病组织或肿瘤的同时保护健康组织 利润。这种屏蔽使 CivaSheet 能够被植入到辐射敏感结构附近，而不会过量使用 – 对于靠近心脏和纵隔的癌症具有巨大的优势。 CivaTech Oncology 在案例研究中证实，CivaSheet 在植入后不会移动，并且 可以为肺癌患者提供大量有益的剂量。 CivaSheet 使这些患者受益匪浅 在初次手术时进行局部放射治疗以防止局部复发，这是一个重要的治疗方法 关心肺癌患者。在 SBIR 快速通道家长资助期间，CivaSheet 在肺部的安全性 癌症患者得到了证明，并确定了其使用的一般手术建议。 此外，SBIR 快速通道家长补助金 (R44CA217587) 支持在 肺癌患者的亚肺叶切除术。植入 CivaSheet 的患者的局部复发率正在研究中 评估并与历史增长率20%进行比较。作为研究的一部分，还监测了急性辐射毒性。 与其他形式的治疗相比，CivaSheet 对邻近纵隔和心肌的辐射要少得多 尚未报告辐射输送和与设备相关的毒性。 要求本行政补充提供临床用 CivaSheets 的生产和供应预算 试用。 SBIR 快速通道家长补助金预算假设 CivaSheet 将通过 CMS 和私人报销 付款人。 CivaSheet 不予报销，它极大地影响了完成这项拟议工作并提供服务的能力 接触患者。有了这个行政补充，CivaTech Oncology 将能够更快地完成 临床试验。 CivaSheet 是一款真正独特的近距离治疗设备，有潜力成为第一道防线 对于局部癌症。 CivaTech Oncology 致力于为多种癌症患者提供 CivaSheet 迹象。