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肺癌新型单向PD-103 Civa Sheet的临床评价 CivaTech Oncology的使命是直接为局部肿瘤提供改进的放射治疗。该公司拥有 开发了一种新型的、聚合物封装的膜状辐射源，它只在细胞的一侧发射辐射 设备-CivaSheet®。这种定向源与开放和微创外科技术兼容，并具有 FDA批准将其用作主要或联合癌症治疗。CivaSheet是一种可生物吸收的植入物，可以 在初次手术时应用。Civa Sheet减少了手术和放射治疗之间的时间，这是 这对病人是有好处的。此外，CivaSheet可以在照射患病组织或肿瘤的同时保护健康组织 保证金。这种屏蔽使CivaSheet能够被植入靠近辐射敏感结构，而不会过量使用-a 对于心脏和纵隔附近的癌症来说是巨大的优势。 CivaTech肿瘤学在案例研究中证实，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通过以下方式极大地帮助这些患者 在初次手术时进行局部放射治疗，以防止局部复发，这是一项重要的 关心肺癌患者。在SBIR快速通道家长赠款的过程中，Civa Sheet在肺部的安全性 对癌症患者进行了演示，并定义了使用它的普通外科建议。 此外，SBIR Fast Track Parent Grant(R44CA217587)支持一项临床试验，在 肺叶下叶切除术治疗肺癌患者。植入Civa Sheet的患者的局部复发率正在上升 与历史上20%的比率进行了评估和比较。作为研究的一部分，还对急性辐射毒性进行了监测。 与其他形式的放射治疗相比，CivaSheet对邻近纵隔和心肌的辐射显著减少 已有辐射传递和无设备相关毒性的报道。 本行政补编的目的是为生产和供应临床使用的CivaSheet提供预算。 试用版。SBIR Fast Track Parent Grant预算假设CivaSheet将通过CMS和Private报销 付款人。CivaSheet没有得到报销，这极大地影响了完成这项拟议工作并提供 接触病人。有了这份行政副刊，CivaTech Oncology将能够更快地完成 临床试验。CivaSheet是一种真正独特的近距离放射治疗设备，有可能成为第一道防线 治疗局部癌症。CivaTech Oncology致力于以多种方式向癌症患者提供CivaSheet 有迹象表明。