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. Cancer 140, 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.

中文翻译：

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扫描角分辨低相干干涉术前瞻性检测宫颈发育异常

我们目前使用角度分辨低相干干涉术（a / LCI）通过深度分辨核形态学检测来检测宫颈发育异常的前瞻性临床研究。该研究在雅各比医学中心进行，比较了从20名妇女身上获得的80 a / LCI光学活检与共同注册的物理活检的组织病理学诊断。这项研究使用了一种新型仪器，该仪器可以在不重新定位探头的情况下跨子宫颈进行2D扫描。主要研究目标是将性能与以前的临床a / LCI点探针仪器进行比较[Int。癌症140，1447（2017）]，并使用与该研究相同的诊断标准。将组织分为两种方案：非异常增生与异常增生以及低风险与高风险，后者的分类与临床可行的诊断一致。当使用先前建立的决策边界时，获得了高灵敏度（非发育不良与发育异常：0.903，低风险与高风险：1.000）和NPV（分别为0.930和1.000），显示了扫描a / LCI的成功仪器并增强a / LCI在疾病检测中的临床可行性。