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肿瘤学的使命是直接提供改进的放射疗法 肿瘤。 辐射仅发射设备的一侧 - civasheet。 采用开放和微创的手术技术，并具有FDA间隙为主要或或 联合癌症治疗。 初次手术的时间。 这是对患者的好处。 患病的组织或肿瘤边缘。 放射敏感的结构侵入它们 - 腹部癌症的优势。 在第一阶段，Civatech肿瘤学将确认Civasheet在植入后不会移动 可以在惠普期间植入那种优秀的剂量。 胰腺切除的程序 - 可切除的胰腺特征的护理程序 Civasheet将通过提供初始手术的辐射底色来使这些患者受益 胰腺癌的延迟是一种侵略性疾病。 我的治疗周期更适合癌症的癌症类型，这些癌症是在I期迅速增殖的。 将评估有关其在该患者人群中使用的Civasheet和一般建议。 评估团队将审查临床手提道，植入物计划，样本剂量法可以是 疼痛，最终是评估临床评估的每个患者案例 团队将同意现场的医生，以继续治疗第二阶段的患者。 第二阶段将由两个并发的临床组成，探索Civasheet 可切除的胰腺癌患者的单一疗法或增强治疗。 患者植入了目前的30％的Civasheet 每位患者的生命，疼痛和死亡率将受到监测。 递送到邻近的十二指肠，胃和利物菌，并降低副作用。 它将提供保形剂量，降低感染的风险，并可能减少有关治疗的一面 效果。 影响设备增加知识并受益于未来的手术程序。 Civasheet是一种真正独特的Brashytherapy手段，有可能成为第一行 局部癌症的防御。 癌症患者有多种适应症。