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A Quality Control Program for Quantitative MRI DataAcquisition and Analysis in Multi-site Clinical Trials

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44CA235820-02
Agency Tracking Number: R44CA235820
Amount: $843,717.00
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): 2021-08-31
Small Business Information
4601 NAUTILUS CT, STE 100, Boulder, CO, 80301-3290
DUNS: 080811533
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 TODOR KARAULANOV
 (303) 552-3580
 tkaraulanov@qalibre-md.com
Business Contact
 CRAIG BURNS
Phone: (720) 996-0256
Email: cburns@hpd-online.com
Research Institution
N/A
Abstract
Project Summary Abstract There has been a shift to greater use of neadjuvant chemotherapyNACTin the clinical management of cancerOften used in breast cancer to provide systemic treatment for possible or apparent metastatic diseaseNACT also reduces the primary tumor size and facilitates breast conservationQuantitative magnetic resonance imagingqMRIis an effective diagnostic for monitoring tumor regressionThere are many methodologies being developed for monitoring cancer in vivoincluding contrast agent washoutvolumetryand more recently correlating apparent diffusion coefficients and proton relaxation times to tumor stagingSuch imaging biomarkers are predictive of the pathological complete responsepCRoutcome prior to surgeryThis enables physicians to provideevidence basedtreatment modifications to reduce deleterious side effects and improve patient outcomesTo obtain quantitative data from MR imagesthe variations that occur in imaging as a result of hardware and software differences between MRI manufacturers and day to day operations must be quantifiedIn MRIthe data depends on the protocols used to acquire the imageresulting in inconsistencies if even one parameter in the protocol changesThe goal of the proposed work is to produce and develop and disseminate a ground truth physical standard and quality control program for comparison of MRI scanners in the multisite I SPYACRINtrials monitoring pre operative chemotherapy treatments in the reduction of tumor sizeThe physical standard is an anthropomorphic breast phantom capable of fitting into all commercial breast coilsIt contains novel human tissue mimics and geometric standards with values traceable to the National Institute of Standards and TechnologyNISTAnalysis software capable of protocol compliance checksrapid identification of the regions of interestand comparison to ground truth values as measured by NIST will be developed to complement the physical standardThis will enable qualification of sites and quantification of error resulting from scanner performance aloneGiven the wide breadth of parameter space that MRI protocols encompasspart of the proposed effort will include the development of protocols specific to image acquisition of tumor volumes and for measuring the apparent diffusion coefficient within the tumor volumes as compared to surrounding healthy tissue Project NarrativeQuantitative imaging complements precision medicine initiatives by providing a noninvasive method of monitoring gene specific in vivo treatment of diseases ranging from cancer to neurological disordersTo realize quantitative imagingvariations in imaging hardwaresoftwareand procedures must be mitigatedThis project will develop a quality assurance and quality control procedure for multisite clinical trials involved in monitoring therapeutic efficacy using MR breast imaging

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

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