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J. Hayenga



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    MA01 - Improvement and Implementation of Lung Cancer Screening (ID 368)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Radiology/Staging/Screening
    • Presentations: 2
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      MA01.02 - Non-Invasive LuCED® Test for Endobronchial Dysplasia, Enabling Chemoprevention Therapy with Drugs Such as Iloprost (ID 3866)

      11:06 - 11:12  |  Author(s): J. Hayenga

      • Abstract
      • Presentation
      • Slides

      Background:
      The LuCED test for early stage lung cancer detects rare abnormal cells that are exfoliated from tumors into sputum and promotes cancer case detection with >92% sensitivity and >95% specificity. Additionally, the LuCED test detects endobronchial lung dysplasia to triage patients with pre-cancer to chemoprevention therapy involving drugs such as Iloprost that show potential for reversing dysplasia. This test is complementary to lung cancer screening methods such as LDCT that do not detect dysplasia. We discuss the performance of the LuCED test for the non-invasive detection of endobronchial dysplasia.

      Methods:
      We analyzed 23,188 normal, 690 cancer, and 65 moderate/severe dysplasia cells from patient sputum. Each individual cell was imaged in 3D using the Cell-CT. Cells were analyzed to measure 594 3D structural biomarkers. Classifiers were developed with cytopathology as the gold standard to predict stages of carcinogenesis, from normal to dysplasia and cancer. The classifier output was binned into two diagnostic indications: 1) cancer vs. all other cell types; and 2) moderate/severe dysplasia vs. all other cell types.

      Results:
      Areas under ROC curves for the two diagnostic bins were both = 0.993. Thresholds were chosen to yield case specificity >95%. Using these thresholds, cell classification sensitivity of 75% was measured for cancer and dysplasia detection. Since abnormal sputum typically contains at least three abnormal cells the cancer case detection sensitivity is at least {100% x [1 – (1 - 0.75)[3]]} = 98%.Figure 1 Figure 1 shows ROC curves plus examples of cells imaged in 3D by the Cell-CT.



      Conclusion:
      This study demonstrates the feasibility of using the LuCED test to detect endobronchial dysplasia in the lung, achieving an estimated 98% case sensitivity and 95% case specificity. Future efforts will include testing on independent sets. Importantly, the non-invasive detection of dysplasia by LuCED testing may enable chemoprevention of lung cancer using drugs such as Iloprost.

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      MA01.03 - The Non-Invasive LuCED® Test for Detection of Early Stage Lung Cancer (ID 3867)

      11:12 - 11:18  |  Author(s): J. Hayenga

      • Abstract
      • Presentation
      • Slides

      Background:
      LDCT screening for lung cancer often triggers follow-up scans for indeterminate nodules. The non-invasive LuCED test for detection of early stage lung cancer may resolve nodule findings and reduce LDCT false positives. In LuCED, patient sputum is analyzed by the Cell-CT® which computes 3D images of single cells allowing measurement of 3D structural biomarkers to identify potential abnormal cells. Final case disposition is determined through cytology review of these cells. Example images of abnormal cells identified by LuCED are shown in the figure. Figure 1



      Methods:
      Sputum samples from 127 patients were processed by LuCED: 65 patients had biopsy-confirmed lung cancer; and 62 patients were normal controls. Sensitivity was computed as the percentage of cancer cases where abnormal cells were found by LuCED. Generally, abnormal cells found in a case otherwise understood to be normal could constitute a diagnostic overcall and counted as a false positive. However, a finding of abundant (>5) abnormal cells in cases understood to be normal indicates discovery of a possible occult cancer or dysplastic lesion. Accordingly, these cases were not included in specificity calculations.

      Results:
      For cancer cases, the histology included adenocarcinoma (29 cases), squamous cancer (24), small cell lung cancer (5) and undifferentiated cancer (7); representing stages 1 (14), 2 (11), 3 (25), 4 (14), and unknown (1). Abnormal cells were found in 61 of 65 cancer cases for sensitivity of 93.8%. For stage 1 and 2 cancer, sensitivity was 88%. Ten cells exhibiting changes consistent with atypical adenomatous hyperplasia were found in one case. After removal, there remained two false positive cases, leading to specificity of 96.7% (N = 61).

      Conclusion:
      The LuCED test demonstrates accurate detection of early stage lung cancer with the potential of detecting pre-cancerous conditions of the lung. Results suggest that suspicious nodules may be efficiently reconciled by LuCED when used adjunctively with LDCT.

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