RADIOPHARMACEUTICAL IMAGING AND DOSIMETRY, LLC — Department of Health and Human Services SBIR Phase I: NCI

Description

Radiopharmaceutical therapyRPTis an emerging cancer treatment that delivers radiation directly to cancer cellsThe recent FDA approval ofRa Xofigotmfor resistant metastatic prostate cancer and its commercial success 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 therapeutic radionuclides such as Luand alpha emitters such as Pball are indicators that RPT is poised to become an important tool for cancer therapyThe RPT marketaccording to a BCC Research Reportis expected to increase annually bybetweenandto a total value of just over $billionproviding increased opportunities for dosimetry servicesClinicaltrials gov lists more thantrials investigating this modalitymore thanpharmaceutical companies are working in RPTincluding Roche Genetechand Bayer AlgetaFDA approval of RPT agents requires tumor and normal tissue dose estimatesEuropean regulations mandate personalized dosimetryOptimal use of RPTs is likely to require a precision medicine approach based on quantitative imaging and dosimetryThe founders of this companyRadiopharmaceutical Imaging and DosimetryLLCRAPIDhave IP developed over a combinedyears of NIH Rgrant support in quantitative imaging of radionuclides used in RPTincluding challenging radionuclides like Ya beta emitterRaand IandD dosimetry and radiobiological modeling methods to predict response to cancer therapyThere are no commercial software tools or service providers and very limited expertise to perform these calculationsAs a resultseveral companies have contracted with our labs to perform these calculationsHoweverthe current software implementing the IP is not efficient enough to support a commercial serviceTo provide such a service it is necessary to develop a comprehensive quantitative imaging and dosimetry software tool chain with a browser based GUIthat is user friendly and runs the computationally intensive activities on commodity cloud based compute serversTo demonstrate the feasibility of developing such a tool we propose todevelop a browser based GUI for image registration and segmentation of multi modality images acquired at multiple time pointsdesign and implement a server side framework for authentication and granting privileges to the browser based GUI indesign and develop an integrated quantitative imaging and dosimetry tool chain using a conventional GUIandtest and validate the tools developed in aimson a large anonymized database of Lupeptide therapy patient datasetsAccomplishing these aims would demonstrate the feasibility and provide the basis for development and validation of a collaborative web based quantitative imaging and dosimetry system for RPT in a Phase II project Radiopharmaceutical therapy is a new and underused cancer therapy modalityClinical trials of RPTagents require and optimal therapeutic regimens are likely to be based on quantitative imagingand dosimetry to predict tumor response and normal organ toxicityThis project seeks todemonstrate the feasibility of developing a software tool chain to enable a dosimetry serviceproduct for RPT cancer developers and serve as the basis for a future dosimetry software service orproduct for clinical RPT therapy