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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

基本信息

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
项目类别：
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

项目摘要

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的使命是提供直接针对局部的改进放射治疗