Kendall Wesley Y, Ho Derek, Chu Kengyeh, Zinaman Michael, Wieland Daryl, Moragne Kandis, Wax Adam
Department of Biomedical Engineering, Duke University, Durham, NC 27708, USA.
Department of Mechanical Engineering and Materials Science, Duke University, Durham, NC 27708, USA.
Biomed Opt Express. 2020 Aug 20;11(9):5197-5211. doi: 10.1364/BOE.401000. eCollection 2020 Sep 1.
We present a prospective clinical study using angle-resolved low-coherence interferometry (a/LCI) to detect cervical dysplasia via depth resolved nuclear morphology measurements. The study, performed at the Jacobi Medical Center, compares 80 a/LCI optical biopsies taken from 20 women with histopathological tissue diagnosis of co-registered physical biopsies. A novel instrument was used for this study that enables 2D scanning across the cervix without repositioning the probe. The main study goal was to compare performance with a previous clinical a/LCI point-probe instrument [Int. J. Cancer140, 1447 (2017)] and use the same diagnostic criteria as in that study. Tissue was classified in two schemes: non-dysplastic vs. dysplastic and low-risk vs. high-risk, with the latter classification aligned with clinically actionable diagnosis. High sensitivity (non-dysplastic vs. dysplastic: 0.903, low-risk vs. high-risk: 1.000) and NPV (0.930 and 1.000 respectively) were obtained when using the previously established decision boundaries, showing the success of the scanning a/LCI instrument and reinforcing the clinical viability of a/LCI in disease detection.
我们开展了一项前瞻性临床研究，使用角分辨低相干干涉测量法（a/LCI）通过深度分辨核形态测量来检测宫颈发育异常。该研究在雅各比医疗中心进行，比较了从20名女性身上采集的80次a/LCI光学活检结果与共配准的物理活检的组织病理学诊断结果。本研究使用了一种新型仪器，该仪器能够在不重新定位探头的情况下对宫颈进行二维扫描。主要研究目标是将其性能与之前的临床a/LCI点探头仪器[《国际癌症杂志》140, 1447 (2017)]进行比较，并采用与该研究相同的诊断标准。组织按两种方案分类：非发育异常与发育异常以及低风险与高风险，后一种分类与临床可操作诊断一致。使用先前确定的决策边界时，获得了高灵敏度（非发育异常与发育异常：0.903，低风险与高风险：1.000）和阴性预测值（分别为0.930和1.000），表明扫描a/LCI仪器取得了成功，并强化了a/LCI在疾病检测中的临床可行性。
