SIMPHOTEK, INC. — Department of Health and Human Services SBIR Phase I: 102

Description

Over worldwide cases of head and neck Handamp N cancer occur annually Despite aggressive treatment about of Handamp N cancers recur and progress Recent studies of interstitial PDT I PDT have shown promising results in the treatment of patients with locally advanced Handamp N cancer that fail standard therapies I PDT provides a means to treat cancerous tumors while minimizing damage to surrounding tissues and does not exhibit cumulative cell toxicities distinguishing it from radiation therapy However the recent I PDT studies do not use pre treatment planning nor treatment monitoring with real time light dosimetry to guide the therapy As compared to radiation therapy treatment planning and monitoring for I PDT remain rudimentary since patient and tumor specific photokinetics factors such as tumor oxygenation photosensitizer PS levels and singlet oxygen dose that are critical to the delivery of effective treatment doses are not taken into account The development of treatment planning and monitoring tools that take into account these factors will fill an unmet clinical need and provide for individualized patient treatment An effective I PDT treatment planning and monitoring system is expected to improve therapeutic outcomes reduce the need for repeat I PDT or additional cell killing therapy and could therefore reduce overall costs in the per patient delivery of cancer related therapy and care This SBIR Phase I proposal will be done by Simphotek Inc with a subcontract to Roswell Park Cancer Institute RPCI The major objective is to develop new prototype software and hardware tools to enable interstitial Intensity Modulated Photodynamic Therapy i IMPDT The new tools will combine simulations of PS photokinetics with light propagation using fast finite element FE analysis techniques that include light scattering and absorption In the future these tools will create a platform to provide real time treatment guidance and dose modifications during I PDT Simphotek is a world leader in developing sophisticated photokinetics software and RPCI is a world leader in the fields of I PDT and FE analysis of Handamp N cancers This Phase I SBIR has three major aims Aim is to develop and confirm the accuracy of new customized FE software code and hardware tools to calculate the light dose for I PDT To determine simulation accuracy calculations using the new tools will be compared to phantom measurements done at RPCI mimicking the anatomy of Handamp N cancer patients Aim is to adapt Simphotekandapos s photokinetics code to calculate PS fluorescence PS photobleaching PS concentration and singlet oxygen dose Aim is to determine the feasibility of combining the new FE code and the modified photokinetics software code into a unified platform code After initial development in Phase I the prototype treatment planning and monitoring tools will be further advanced in Phase II Clinical trials will be performed in Phase III to determine if the platform code and hardware provides I PDT physicians and researchers with accurate light dose distributions in cancer tumors and improves patient outcomes The general lack of effective treatment planning and dosimetry tools that can provide patients with individualized cancer treatments is a critical barrier to continued progress in interstitial photodynamic therapy I PDT Simphotek Inc and I PDT experts at Roswell Park Cancer Institute propose to fill this unmet need by combining light transport and photokinetics computational methods for I PDT to develop unique prototype software and hardware dosimetry tools that can be easily utilized by I PDT physicians and researchers An effective I PDT treatment planning and dosimetry system is expected to improve patient outcomes reduce the occurrence of under and over exposure treatments and therefore reduce overall costs in cancer related therapy