SBIR-STTR Award

Product Development Of A Brain Tumor Perfusion Imaging Technology
Award last edited on: 7/3/12

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$904,331
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Timothy D Dondlinger

Company Information

Imaging Biometrics LLC (AKA: IB)

3416 Watertown Plank Road Suite 260
Elm Grove, WI 53122
   (262) 439-8252
   info@imagingbiometrics.com
   www.imagingbiometrics.com
Location: Single
Congr. District: 05
County: Waukesha

Phase I

Contract Number: 1R43CA134031-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2008
Phase I Amount
$107,000
Primary brain tumors are the leading cause of cancer-related deaths in children and the fourth leading cause of cancer-related deaths in people under the age of 54. Recently, a significant increase in the incidence of brain tumors has been observed in people over the age of 60. Survival for adult primary brain tumors ranges from 8-9 months to 2-3 years despite standard therapies such as surgery, radiation therapy and chemotherapy. The most aggressive brain tumors are those characterized by the formation of new blood vessels a process called angiogenesis. Consequently, new drugs that inhibit angiogenesis (i.e. antiangiogenic drugs), are a particularly promising alternative for this patient population. To capitalize on this promise a reliable and reproducible, non-invasive method is needed to efficiently optimize and evaluate new therapeutic approaches to brain tumors. Dynamic susceptibility contrast (DSC) MRI methods, which allow the creation of relative cerebral blood volume (rCBV), cerebral blood flow (CBF) and mean transit time (MTT) maps, have the potential to fulfill this promise. However, despite the widespread and well-published potential, the clinical adoption rate of DSC studies in brain tumors has been impeded. This has been attributed to the lack of one or two generally accepted methods for use in brain tumors. To address this issue a DSC comparison study was performed in the laboratory of Dr. Schmainda (co-investigator on this grant). This study was designed to directly compare, in brain tumor patients, the most commonly used and published DSC acquisition and analysis methods. The results of this study demonstrate that there are two (of 26 tested) approaches that appear to be the most accurate and reliable. The first approach uses currently available MR imaging sequences and a post- processing correction algorithm. The 2nd approach is a new approach, which was developed as a result of the understanding derived from the comparison study. This approach, for which Imaging Biometrics has a patent pending, entails using a dual-echo SPIRAL imaging sequence in combination with a post-processing correction algorithm. These two approaches form the core of the perfusion technology that Imaging Biometrics LLC proposes to develop. The overall goal is to make this software user-friendly and widely available to both the research and clinical community. To accomplish this goal the following two specific aims will be addressed: Aim 1: To convert the research laboratory code into code that is compliant with industry and FDA standards. The approach will be to rewrite the currently available post-processing software, developed for research purposes, into a base library using platform-independent C/C++. Aim 2: To adapt the software to plug into an existing vendor s viewing and display workstation. The approach will be to implement the appropriate software interfaces to allow the post- processing software in the base library of Aim 1 to be integrated as a feature into open-source and commercial image viewing software. Addressing these aims will enable the translation of robust perfusion technologies from the laboratory into the clinic. Ultimately, this should aid in the discovery of new drugs and therapeutic strategies that can be adapted on a per-patient basis.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.

Phase II

Contract Number: 2R44CA134031-02A2
Start Date: 9/1/08    Completed: 11/30/12
Phase II year
2010
(last award dollars: 2011)
Phase II Amount
$797,331

The goal of this Phase II SBIR proposal is to expand upon the research and development efforts, begun in Phase I, with new enhancements and product offerings, while also taking the initial steps to position the Company for a multi-center clinical trial, planned for Phase III. Phase I efforts have led to the development and commercialization of the Company's first product, IB NeuroTM 1.0, which received FDA 510K clearance for indications of brain tumors and stroke. This product uses perfusion analysis algorithms, which were proven to be the most robust in a multi-year comparison study performed in patients with brain tumors. A key element of the product is the leakage correction algorithms, critical for the accurate evaluation of brain tumors. Currently no other perfusion analysis software product with FDA clearance incorporates leakage correction algorithms. Therefore, the IB Neuro 1.0 product makes available, for the first time, advanced and proven algorithms for the analysis of MRI perfusion data in a robust and easy-to-use fashion. Given this early success, the specific objectives of this Phase II proposal are to extend the functionality of IB NeuroTM in three important ways. First, additional tools will be added to enable comparison of imaging data across studies. This capability is especially important for the most efficient and accurate evaluation of both standard treatments (such as chemotherapy and radiation therapy) and for the newly available and promising biologic agents that target a tumor's new blood vessel growth (angiogenesis). Second, the Company's patented dual-echo perfusion technology will be developed as part of IB Neuro 1.1. With this proprietary technology DSC (dynamic susceptibility contrast) and DCE (dynamic contrast enhanced) perfusion data can be simultaneously collected while using only a single dose of contrast agent. IB Neuro 1.1. will incorporate the tools to generate relevant perfusion parameters including CBV (cerebral blood volume), CBF (cerebral blood flow) as well as Ktrans, a marker of vascular permeability. A third objective is to incorporate the functionality necessary to more specifically support the evaluation of perfusion data for the evaluation of stroke. Each of these product development objectives will be accomplished in the context of receiving frequent feedback from the Company's luminary sites. This will position the Company for the multi-center trials planned for Phase III. Overall the technological niche of IB, which is to develop advanced imaging analysis tools that plug into existing vendors'systems, will enable advanced imaging options to become more widely available to clinics and therefore patients in a cost-effective manner. The result will be to provide the best and most state-of-the- art patient care on a more widespread basis. This has the potential to shift current clinical practice paradigms with regard to how treatments are planned and monitored, as none of these proven advanced technologies have been previously available on a wide-spread basis. , ,

Public Health Relevance:
The goal of this Phase II SBIR proposal is to enable the Company, Imaging Biometrics LLC, to continue its development and distribution of innovative and proven perfusion and diffusion analysis software for the evaluation of brain tumors and stroke. While stand-alone options are available, the primary approach is to develop the software to plug into existing vendors'systems. With this approach the best and most up-to-date image analysis software can be made available on a widespread and cost-effective basis, which has the potential to shift current clinical practice paradigms for treatment planning and monitoring.

Thesaurus Terms:
Address;Algorithms;Angiogenesis Antagonists;Angiogenesis Blockers;Angiogenesis Inhibitors;Angiogenetic Antagonists;Angiogenic Antagonists;Angiostatic Agents;Anti-Angiogenetic Agents;Anti-Angiogenic Agents;Anti-Angiogenic Drugs;Antiangiogenesis Agents;Antiangiogenic Agents;Apoplexy;Area;Arts;Biometrics;Biometry;Biometry And Biostatistics;Biostatistics;Blood Vessels;Blood Volume;Brain;Brain Neoplasia;Brain Neoplasms;Brain Tumors;Cancer Radiotherapy;Cerebral Stroke;Cerebrovascular Apoplexy;Cerebrovascular Circulation;Cerebrovascular Stroke;Cerebrovascular Accident;Cerebrum;Clinic;Computer Programs;Computer Software;Contrast Agent;Contrast Drugs;Contrast Media;Data;Development;Development And Research;Diffusion;Disease;Disorder;Dose;E-Mail;Electronic Mail;Elements;Email;Encephalon;Encephalons;Evaluation;Extravasation;Feedback;Future;Generalized Growth;Generations;Goals;Growth;Health Care Industry;Healthcare Industry;Human Resources;Image;Image Analyses;Image Analysis;Imaging Technology;Industry, Healthcare;Infarction;Inhibitors, Angiogenetic;Inhibitors, Angiogenic;Ischemia;Leakage;Legal Patent;Manpower;Maps;Methods;Monitor;Multi-Institutional Clinical Trial;Multi-Center Clinical Study;Multi-Center Clinical Trial;Multi-Site Clinical Study;Multi-Site Clinical Trial;Neovascularization Inhibitors;Nervous System, Brain;Patents;Patient Care;Patient Care Delivery;Patients;Perfusion;Phase;Physicians;Plug-In;Position;Positioning Attribute;Predisposition;R & D;R&D;R01 Mechanism;R01 Program;Roc Analysis;Rpg;Radiation Therapy;Radiopaque Media;Radiotherapeutics;Radiotherapy;Reporting;Research Grants;Research Project Grants;Research Projects;Research Projects, R-Series;Risk;Sbir;Sbirs (R43/44);Site;Site Visit;Small Business Innovation Research;Small Business Innovation Research Grant;Software;Solid Neoplasm;Solid Tumor;Spillage;Stroke;Susceptibility;System;System, Loinc Axis 4;Technology;Testing;Time;Tissue Growth;Translating;Translatings;Validation;Vascular Accident, Brain;Vascular Permeabilities;Vendor;Weight;Angiogenesis;Antiangiogenic;Base;Brain Attack;Cerebral Blood Flow;Cerebral Circulation;Cerebral Vascular Accident;Cerebrocirculation;Chemotherapy;Clinical Practice;Commercialization;Computer Program/Software;Computerized Data Processing;Conference;Cost;Data Processing;Develop Software;Developing Computer Software;Disease/Disorder;Image Evaluation;Imaging;Imaging Modality;Indexing;Infarct;Innovate;Innovation;Innovative;Interest;Irradiation;Language Translation;Meetings;Multi Center Clinical Study;Multi Center Clinical Trial;Multi Site Clinical Study;Multi Site Clinical Trial;Neuro-Oncology;Novel;Ontogeny;Patient Population;Personnel;Product Development;Public Health Relevance;Research And Development;Signal Processing;Software Development;Standard Care;Statistics/Biometry;Stroke;Success;Symposium;Tool;Treatment Planning;Trend;Tumor;Tumors In The Brain;Vascular