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QI-Bench: Optimizing Performance Through Characterization.

Quantitative imaging applications such as imaging biomarkers are developed for use in the clinical care of patients and in the conduct of clinical trials of therapy. In clinical practice, imaging biomarkers are intended to (a) detect and characterize disease, before, during or after a course of therapy, and (b) predict the course of disease, with or without therapy. In clinical research, imaging biomarkers are intended to be used in defining endpoints of clinical trials. A precondition for the adoption of the biomarker for use in either setting is the demonstration of the ability to standardize the biomarker across imaging devices and clinical centers and the assessment of the biomarker’s reproducibility.

Although qualitative biomarkers can be useful, the medical community currently emphasizes the need for objective, ideally quantitative, biomarkers. Extracting quantitative data from medical images generally requires a software algorithm. In this grant application, “biomarker” refers to the measurement derived from an imaging method, and “device” or “test” refers to the hardware/software used to generate the image and extract the measurement. Regulatory approval for clinical use and regulatory qualification for research use depend on demonstrating proof of performance relative to the intended application of the biomarker:

  • In a defined patient population,
  • For a specific biological phenomenon associated with a known disease state,
  • With evidence in large patient populations, and
  • Externally validated.

In this project, we provide open-source informatics tooling used to characterize the performance of quantitative medical imaging as needed to advance the field. These tools may be deployed internal to an organization or used for collaborative work across organizations. The data on which they work may be accessible only to identified individuals, or more broadly in an open archive, to suit the specific project purpose.

Contents

Our Plan

Our activities in the first formal program year was to analyze user requirements, create demonstrator technology for key pieces, and to develop design concepts for the system as a whole and its principal parts. Starting in the fall of 2011, we initiated an iterative development process to create the services and define roles and work instructions to use them by various stakeholders in the community.

Test plans, protocols, and reports are formally stored in the Design History File for each instance of the installed software.

User Needs and Requirements Analysis

The specification stack is bootstrapped with a user needs analysis comprised of three documents, the Basic Story Board (BSB), the Enterprise Use Case (EUC), and the System Use Cases (SUC).

Flowdown:

Installation Instructions

Component User (simplified) Full developer
Overall QI-Bench pending Available
Specify pending Available
Formulate pending Available
Execute pending Available
Analyze pending Available
Package pending pending
Iterate pending pending

Lab Protocol

Developer's Guide

Full Group Meeting Minutes

Investigators and Collaborators

In collaboration with:

With funding by the Measurement Science and Engineering (MSE) Research Grants Programs, NIST.

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