Development and Validation of a Collaborative Web-Based Quantitative Imaging and Dosimetry System for Radiopharmaceutical Therapy

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