Rationale and Objectives
Lung cancer is the leading cause of cancer death in the United States. Mortality outcomes have improved only modestly over the past 30 years. There is intense focus on the development of better treatments for lung cancer. Major issues include the cost and time duration of the clinical trials required to establish the utility of a drug so that it can be formally approved by regulatory agencies. In clinical settings, biomarkers that accelerate assessments of responses to treatment could benefit patients by providing earlier diagnoses of progressive disease, particularly when there are multiple options for treatment, and the effects of toxicity from one treatment tend to limit the ability to administer the next line of therapy.
Materials and Methods
Quantifying longitudinal changes in tumor volumes using computed tomography could eventually become a more useful surrogate endpoint for assessing tumor responses or progression events than simple unidimensional measurements.
Results
The authors review the historical development of response measurements in lung cancer, set out the medical context for specifying volumetric imaging requirements and goals, compare volumetric technique to conventional methods, and identify the imaging profiles being pursued.
Conclusion
The Quantitative Imaging Biomarkers Alliance is investigating volumetric computed tomographic acquisition and analytic methods to increase the analytic power per subject enrolled in clinical trials to reduce the number of total subjects needed or shorten the length of time an individual needs to be followed to reliably establish drug response.
Computed tomographic imaging technology has continued to improve over the past three decades . The benefits of imaging for diagnosis, staging, and restaging cancer are now well established . However, assessing responses to treatment has remained predominantly qualitative, with limited use of electronic caliper measurements of unidimensional or bidimensional line lengths on a single two-dimensional image slice. Anecdotal evidence continues to emerge suggesting that line-length measurements may be misleading compared to volumetric measurements of the tumor mass. However, early attempts to quantify entire tumor volumes proved to be labor intensive and not adequately reproducible . More recent attempts have been encouraging , but additional studies are needed for future consideration as an acceptable imaging endpoint by regulatory authorities.
This report outlines the initial clinical emphasis of the Volumetric CT Technical Committee of the Radiological Society of North America’s (RSNA) Quantitative Imaging Biomarkers Alliance (QIBA). The potential benefits of the effort are described, the roles of each of the stakeholders are explained, and a staged approach for moving the process forward is explained.
Opportunity
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Historical development of response measurements in lung cancer
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The medical context for volumetric imaging
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Cancer staging
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Table 1
Summary of Image-processing Issues Relative to Stages of Lung Cancer
Stage % of Cases % 5-year Survival Imaging Focus/Therapy Focus Imaging Tool Issues Thoracic Segmentation High-resolution Techniques I 16 49 Primary tumor/neoadjuvant and adjuvant therapy sCT Small cancers surrounded by air Can be straightforward Needed II/III 35 15.2 Primary, hilar and mediastinal lymph nodes/combined modality sCT, PET Larger tumors and nodes abut other structures Often challenging Optional IV 41 3 Primary/regional nodes and metastatic sites/chemotherapy sCT, PET, bone, brain scans Tumor response often determined outside of the chest Often challenging Optional
PET, positron emission tomography; sCT, spiral computed tomography.
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Volumetric technique versus conventional methods: preliminary clinical studies in non-small-cell lung cancer
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Lung cancer profiles
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Next steps
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Acknowledgments
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