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Development and Validation of a Collaborative Web/Cloud-Based Dosimetry System for Radiopharmaceutical Therapy.

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA213782-02
Agency Tracking Number: R44CA213782
Amount: $1,868,036.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 101
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-17
Award End Date (Contract End Date): 2022-07-31
Small Business Information
1800 GOUGH ST
Baltimore, MD 21231-2607
United States
DUNS: 080200015
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MICHAEL GHALY
 (443) 470-0824
 mghaly@rapiddosimetry.com
Business Contact
 GEORGE SGOUROS
Phone: (443) 470-0824
Email: gsgouros@gmail.com
Research Institution
N/A
Abstract

Project SummaryRadiopharmaceutical therapy (RPT) – the use of targeted radionuclides to deliver radiation specifically to
cancer cells and their microenvironment – is a fundamentally different approach to cancer therapy that is growing,
with a substantial number of large and small pharmaceuticals companies developing products in this area and
radionuclide producers making substantial investments in scaling up production. This is especially true in the
area of alpha emitters. The dosimetric evaluation of therapeutic radiopharmaceuticals is a key requirement for
regulatory approval and optimal administration of RPTs, especially in combination with external beam radiation
therapy. This project will provide a cloud-based dosimetry software service, delivered through a web-browser,
that includes the full complement of methods needed for dosimetry in the context of obtaining regulatory approval
of RPTs and, ultimately, for optimal clinical delivery. Providing this in a cloud-based system will enable a variety
of models for selling the service that do not require a large up-front capital investment for clinics or
radiopharmaceutical developers. It also will provide access to expert advice, customization, and dosimetry
services, and allow for collaboration between developers, dosimetry experts, and clinical sites. To accomplish
the goal of developing this cloud-based web-browser-delivered RPT dosimetry software service, we propose the
following specific aims: (1) Design, develop and implement a web/cloud-based integrated software system for
treatment planning of RPT therapy; (2) design and implement a full server-side framework for subscription,
authentication, and granting collaborative privileges for the various processes and data in the dosimetry pipeline;
(3) optimize and adapt the four most computationally intensive processes for a multi-processor cloud-based
compute environment; (4) apply and evaluate the toolchain developed in aims 1-3 to phantom, simulated and
existing patient data. Successful completion of this project will produce a cloud-based software system delivered
to the user via a web browser that provides an integrated, streamlined, robust, state-of-the-art system for RPT
treatment planning. This system would enable a collaborative approach to multi-center clinical trials and
eventually to clinical delivery of optimally dosed RPT.Projective NarrativeRadiopharmaceutical therapy is an emerging cancer therapy modality involving the targeted
delivery of radiation to tumors using tumor-targeting molecules. The dosimetric evaluation of the
therapeutic radiopharmaceuticals is a key requirement for regulatory approval and optimal
administration of RPTs. This project seeks to develop a cloud-based software system delivered
to the user via a web browser that provides an integrated, streamlined, robust, state-of-the-art
system for RPT treatment planning; and enables a collaborative approach to multi-center clinical
trials and eventually to the clinical delivery of optimally dosed RPT.

* Information listed above is at the time of submission. *

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