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: 9200280
• 负责人: Kristy Perez
• 金额: $ 29.96万
• 依托单位: CIVATECH ONCOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-13 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9200280
• 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 therapy; Radio; Readiness; Recommendation; Recruitment Activity; Recurrence; Reporting; Research Personnel; Resectable; Resected; Risk; Safety; Sampling; Shapes; 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; meetings; 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。该公司开发了一种新型聚合物封装膜状辐射源 仅在设备的一侧（CivaSheet）发射辐射。该定向源兼容 采用开放式和微创手术技术，并经 FDA 批准可用作主要或 癌症联合治疗。 CivaSheet 是一种部分生物可吸收的植入物，可应用于 初次手术的时间。 CivaSheet 缩短了手术和放射治疗之间的时间， 这对患者来说是有好处的。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 能够被植入到靠近 无需过量剂量即可形成放射敏感结构——这对于腹部癌症来说是一个巨大的优势。 在第一阶段，CivaTech Oncology 将确认 CivaSheet 在植入后不会移动，并且 可以实现出色的剂量测定。 CivaSheet 将在 Whipple 期间植入 胰腺切除手术——可切除胰腺患者的标准护理程序。这 CivaSheet 将通过在初次手术时提供放射治疗来使这些患者受益 尽量减少延误治疗。胰腺癌是一种进展迅速的侵袭性疾病。 更快的治疗周期对于快速增殖的癌症类型来说是理想的选择。在第一阶段，安全性 将评估 CivaSheet 及其在该患者群体中使用的一般建议。临床 评估小组将审查临床试验方案、植入计划、样本剂量测定 实现，并最终根据每个患者案例来评估设备相关事件。临床评价 团队将与现场医生达成一致，继续治疗第二阶段的患者。 II 期将包括两项同时进行的临床试验，探索 CivaSheet 的用途 可切除胰腺癌患者的单一疗法或加强疗法。局部复发率 植入CivaSheet的患者比例将比目前的30%高。此外，质量 每个患者的生命、疼痛和死亡率都将受到监测。 CivaSheet 将减少辐射 输送到邻近的十二指肠、胃和肝脏，应该会减少副作用。此外， 它将提供适形剂量，降低感染风险，并可能减少治疗相关副作用 影响。临床评估团队将审查每个患者病例以讨论患者的具体差异 影响设备以增加知识并有益于未来的外科手术。 CivaSheet 是一款真正独特的近距离放射治疗设备，有潜力成为一线治疗设备 防御局部癌症。 CivaTech Oncology 致力于将 CivaSheet 提供给 多种适应症的癌症患者。