Research Project
9566125
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.
