SBIR/STTR Award attributes
Radiopharmaceutical therapyRPTis an emerging cancer treatment that delivers radiation directly to cancer cellsThe recent commercial success ofRa Xofigotmfor resistant metastatic prostate cancer provides an example of the therapeutic and commercial potential of this modalityIn additiondrug companies have large libraries of targets and targeting moleculesProgress in chelators and commercial availability of alpha emitters such asPb andTh all are indicators that RPT is poised to become an important tool for cancer therapySeveral companies and academic centers are developing drugs based on alpha emittersFor exampleBayer has presented data on Thbased agents targeting CDHERPSMA and FGFRreceptorsTheBCC Research reportRadiopharmaceuticalTechnologies and Global Marketssays that the global radiopharmaceuticals market will grow at aCompound Annual Growth RateCAGRto $B inThe North American market will increase to $B ina CAGR ofDuring the past decade interest in therapeutic radiopharmaceuticals has increasedThe diagnostic applications sector is expected to grow atper yearGrowth of Therapeutic RPTs ofper year is expecteddriven by new radionuclides and approval of newRPTse gXofigoBayer HealthCareCurrentlythere areRPT drugs in various stages of developmentClinicaltrials gov lists more thantrials investigating this modalitymore thanpharmaceutical companies are working on RPTsincluding large companies such as Roche Genetechand Bayer AlgetaFDA approval of RPT agents requires tumor and normal tissue dose estimatesEuropean regulations mandate personalized dosimetryOptimal use of RPTs requires a precision medicine approach based on quantitative imaging and dosimetryThe foundation of this personalized dosimetry approach is quantitative imagingCommercial quantitative SPECT CT software packages have recently become availablebut are designed for diagnostic radiopharmaceuticalsand the methods used are too simple to allow accurate quantitative reconstructions of therapeutic radionuclidesMethods to reconstruct these difficult to image radionuclides are not commercially availableand packages developed in academic laboratories are difficult to use and extendThe overall goal of this project is to demonstrate feasibility of developing and validating a commercial gradeweb basedextensible quantitative reconstruction software framework for therapeutic radionuclidesTo this endwe propose toinvestigate algorithmic improvements to improve accuracy for high energy emissionsspeed up the codes using multi core CPUs and GPUsimplement a web based user interface that enables running reconstructions in a cloud based environment andvalidate the methods forTh andPb using physical experiments on cameras from multiple vendors and realistic simulationsSuccessful completion of this would enable development of a Phase II quantitative reconstruction service essential in development and approval of RPTs and ultimately in delivery of optimal personalized dosing in a precision medicine paradigm Regulatory approval and optimal use of radiopharmaceutical cancer therapies require personalized dosimetrywhich is based on quantitative imaging of the distribution of the therapeutic radionuclideThese radionuclides are difficult to image due to their complex emission spectrumand quantitative reconstruction methods for them are not commercially availableThis project seeks to demonstrate the feasibility of an extensiblecommercial grade software framework for performing quantitative SPECT reconstruction for difficult radionuclides as a cloud based service available with an API for developers and a web interface
