Benefits of CivaSheet for the Patient – A surgical treatment gives the patient the psychological benefit of knowing that the cancer is truly removed. A surgical procedure also allows the surgeon and oncologist to determine the true pathology of the disease and decide future treatment options while in the Operating Room. The CivaSheet is implanted in the surgical margin giving immediate radiation therapy to cure any residual disease. The uni-directional property of the CivaSheet minimizes radiation exposure and radiation-induced side effects while still maintaining the cancer destroying properties of radiation.
The development of a technique to treat lung cancer with the CivaSheet® could have profound social and economic implications for patients. Many of these individuals would have the whole lobe of their lung removed and this would be followed by a course of external beam therapy, even though there is evidence of radiation damage to healthy tissues using External Beam Therapy (EBT). ( list a reference paper). Recurrence most often presents in the region of the primary tumor and that is the reason for targeting this localized area for radiotherapy using the unidirectional CivaSheet.
In the case of cancer located near the mediastinum or near the heart, radiation is not currently an option. If these patients were able to receive radiotherapy, one could potentially expect to see an increase in life span. By providing accurate delivery of radiation directly to the tumor site at the time of a resection, the CivaSheet will reduce immediate side effects and improve longer term survival without the risk of radiation damage to healthy tissue from either external beam or standard brachytherapy. Further, it is possible to deliver a “hotter” dose than standard treatment which is believed will increase cure rates. In fact, it is now realized that the CivaSheet can boost external beam therapy to the curative dose and should improve outcomes in many diseases.
CivaTech Oncology is conducting an NIH/NCI sponsored clinical study to treat lung cancer. Dr. Abe Wu at Memorial Sloan Kettering Cancer Center in NYC is the Principal investigator for the multi-institutional study.
Our clinical partners are enthusiastic supporters of the method to treat lung cancer. The study has successfully completed the feasibility section of the study with patients reporting few, if any, side effects from the use of CivaSheet. CivaSheet is unique in that it provides a potentially curative dose from the minute it is placed in the surgical margin. Unlike external radiation, where the patient is working up to the therapeutic dose that is not reached until about half way through the number of treatments required.
Patients have reported significantly less side effects from the CivaSheet than with other forms of radiation therapy. The dose provided by the CivaSheet in many cases, exceeds the dose that could be delivered with other forms of radiation therapy, including treatments with Proton Beam therapy.
CivaSheet is FDA cleared, meets all nuclear regulatory requirements and AAPM requirements for medical use and has been implanted to treat cancer since 2015.
If you would like to learn more about the Study, go to www.clinicaltrials.gov and search CivaSheet.
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