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Published on: December 19, 2020
Volumetric CT in lung cancer: an example for the qualification of imaging as a biomarker
Andrew J Buckler1, P David Mozley, Lawrence Schwartz
1Buckler Biomedical LLC, Wenham, MA, USA.
Rationale And Objectives:
New ways to understand biology as well as increasing interest in personalized treatments requires new capabilities for the assessment of therapy response. The lack of consensus methods and qualification evidence needed for large-scale multicenter trials, and in turn the standardization that allows them, are widely acknowledged to be the limiting factor in the deployment of qualified imaging biomarkers.
Materials And Methods:
The Quantitative Imaging Biomarker Alliance is organized to establish a methodology whereby multiple stakeholders collaborate. It has charged the Volumetric Computed Tomography (CT) Technical Subcommittee with investigating the technical feasibility and clinical value of quantifying changes over time in either volume or other parameters as biomarkers. The group selected solid tumors of the chest in subjects with lung cancer as its first case in point. Success is defined as sufficiently rigorous improvements in CT-based outcome measures to allow individual patients in clinical settings to switch treatments sooner if they are no longer responding to their current regimens, and reduce the costs of evaluating investigational new drugs to treat lung cancer.
Results:
The team has completed a systems engineering analysis, has begun a roadmap of experimental groundwork, documented profile claims and protocols, and documented a process for imaging biomarker qualification as a general paradigm for qualifying other imaging biomarkers as well.
Conclusion:
This report addresses a procedural template for the qualification of quantitative imaging biomarkers. This mechanism is cost-effective for stakeholders while simultaneously advancing the public health by promoting the use of measures that prove effective.
Insights
A new procedural template enables the qualification of quantitative imaging biomarkers, improving lung cancer treatment assessment. This standardized approach accelerates personalized medicine and reduces drug development costs.
Area of Science:
- Medical imaging
- Biomarker discovery
- Quantitative imaging
Background:
- Personalized medicine requires advanced therapy response assessment.
- Lack of standardized, qualified imaging biomarkers hinders clinical trials and deployment.
- The Quantitative Imaging Biomarker Alliance aims to address these limitations.
Purpose of the Study:
- To establish a collaborative methodology for qualifying quantitative imaging biomarkers.
- To investigate the feasibility and clinical value of volumetric CT biomarkers for solid tumors in lung cancer.
- To improve early detection of therapy response and reduce drug development costs.
Main Methods:
- A systems engineering analysis was conducted.
- A roadmap for experimental groundwork was initiated.
- Profile claims, protocols, and a general paradigm for biomarker qualification were documented.
Main Results:
- A procedural template for qualifying quantitative imaging biomarkers has been developed.
- The process is designed to be cost-effective for all stakeholders.
- This advances public health by promoting effective outcome measures.
Conclusions:
- The developed mechanism provides a procedural template for quantitative imaging biomarker qualification.
- This approach facilitates the standardization needed for large-scale multicenter trials.
- It promotes the use of effective measures, advancing public health and personalized medicine.
