Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Pancreatic Cancers

新型单向 Pd-103 CivaSheet 用于胰腺癌的临床评估

• 批准号: 9558651
• 负责人: Kristy Perez
• 金额: $ 146.46万
• 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: 2017-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9558651
• 关键词: Abdomen; Absorbable Implants; Adjuvant Radiotherapy; Adverse effects; Applications Grants; Brachytherapy; Cancer Patient; Clinical; Clinical Trials; Clinical trial protocol document; Devices; Disease; Dose; Duodenum; Effectiveness; Encapsulated; Evaluation; Event; Excision; External Beam Radiation Therapy; Future; Grant; Implant; Infection; Injury; Institutes; Institution; Instruction; Knowledge; Liver; Localized Malignant Neoplasm; Location; Malignant Neoplasms; Malignant neoplasm of pancreas; Membrane; Methods; Mission; Monitor; Mono-S; Movement; Operative Surgical Procedures; Outcome; Overdose; Pain; Palladium 103; Pancreas; Pancreaticoduodenectomy; Patients; Phase; Physicians; Polymers; Positioning Attribute; Procedures; Proliferating; Protocols documentation; Quality of life; Radiation; Radiation Oncologist; Radiation Tolerance; Radiation therapy; Readiness; Recommendation; Recruitment Activity; Recurrence; Reporting; Research Personnel; Resectable; Resected; Risk; Safety; Sampling; Side; Site; Source; Statistical Data Interpretation; Stomach; Structure; Surgeon; Techniques; Testing; Therapeutic Effect; Time; TimeLine; Tissues; Training; Universities; Work; X-Ray Computed Tomography; arm; cancer therapy; cancer type; clinical research site; cost effective; dosimetry; implantable device; implantation; improved; in vivo; medical schools; minimally invasive; mortality; novel; oncology; patient population; radiosensitive; research clinical testing; 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 huge advantage for cancers in the abdomen. 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 the Whipple procedure for pancreas resection – a standard of care procedure for resectable pancreatic patients. The CivaSheet will benefit these patients by delivering radiation therapy at the time of initial surgery to minimize delay in the treatment. Pancreatic cancer is an aggressive disease that progresses quickly. Faster treatment cycles are ideal for cancer types that proliferate quickly. In Phase I, the safety of CivaSheet and general recommendations for its use in this patient population will be assessed. A Clinical Evaluation Team will review the clinical trial protocols, plans for implants, sample dosimetry that can be achieved and, eventually, each patient case to evaluate device related events. The Clinical Evaluation Team will agree with Physicians on site to continue treating patients in Phase II. The Phase II will consist of two concurrent clinical trials exploring the use of the CivaSheet as monotherapy or boost therapy in resectable pancreatic cancer patients. The rate of local recurrence in patients implanted with CivaSheet will be compared to the current rate of 30%. Additionally, the quality of life, pain, and mortality in each patient will be monitored. CivaSheet will reduce the radiation delivered to adjacent duodenum, stomach, and liver and 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. The Clinical Evaluation Team will review each patient case to discuss patient specific differences impacting the device to increase knowledge and benefit future surgical procedures. 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-一个巨大的优势，在腹部癌症。 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。将在维普莱切除术期间植入CivaSheet 胰腺切除术-可切除胰腺患者的标准护理程序。的 CivaSheet将通过在初次手术时提供放射治疗使这些患者受益， 尽量减少治疗的延误。胰腺癌是一种进展迅速的侵袭性疾病。 更快的治疗周期是快速增殖的癌症类型的理想选择。在第一阶段， 将评估CivaSheet及其在该患者人群中使用的一般建议。临床 评价团队将审查临床试验方案、植入物计划、样品剂量测定， 并最终对每例患者病例进行评估，以评价器械相关事件。临床评价 团队将与研究中心的医生达成一致，继续治疗II期患者。 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 在可切除的胰腺癌患者中的单一疗法或加强疗法。局部复发率 植入CivaSheet的患者将与目前的30%进行比较。此外，质量 将监测每名患者的生命、疼痛和死亡率。CivaSheet将减少辐射 将其递送到邻近的十二指肠、胃和肝脏，并且应该产生较少的副作用。此外，本发明还 它将提供适形剂量，降低感染的风险，并可能减少治疗相关的副作用。 方面的影响.临床评价团队将审查每例患者病例，以讨论患者特定差异 影响器械，以增加知识并使未来的外科手术受益。 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。