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小说，单向PD-103 Civasheet肺癌的临床评估 Civatech肿瘤学的使命是直接为局部肿瘤提供改进的放射疗法。公司有 开发了一种新型的聚合物封装，膜状辐射源，仅在该辐射的一侧发出辐射 设备 - civasheet®。该定向来源与开放且微创的手术技术兼容，并且具有 FDA清除可用作主要或联合癌症治疗。 Civasheet是一种生物吸收的植入物，可以是 在初次手术时应用。 Civasheet减少了手术和放射疗法之间的时间，即 对患者的好处。此外，Civasheet可以在辐照解剖组织或肿瘤的同时屏蔽健康的组织 利润。这种屏蔽使Civasheet能够被植入接近放射敏感的结构而不会过量 - 一个 对于心脏和纵隔附近的癌症而言，巨大的优势。 Civatech肿瘤学在案例研究中证实，Civasheet不会在植入后移动，并且 可以为肺癌患者提供大量和有益的剂量。 Civasheet对这些患者的好处 初次手术时提供局部放射疗法以防止局部复发，这是重要的 关注肺癌患者。在SBIR快速轨道父母赠款的过程中，肺Civasheet的安全 证明了癌症患者，并定义了一般的手术建议。 此外，SBIR快速轨道父母赠款（R44CA217587）支持临床试验以植入civasheet 肺癌患者的司虫切除。植入Civasheet的患者的局部复发率正在 评估并与20％的历史速率进行了比较。作为研究的一部分，还监测了急性辐射毒性。 与其他形式的其他形式相比 辐射输送且未报告与装置相关的毒性。 要求这种行政补充为临床的civasheets生产和供应提供预算 试用。 SBIR快速轨道父母赠款预算假设Civasheet将通过CMS和私人报销 付款人。 Civasheet并未得到报销，这极大地影响了完成这项拟议工作并提供的能力 进入患者。通过这种行政补充，Civatech肿瘤学将能够更快地完成 临床试验。 Civasheet是一种真正独特的近距离放射治疗装置，有可能成为第一道防线 用于局部癌症。 Civatech肿瘤学致力于使癌症患者可用于多个癌症患者 适应症。