Univ. Medical Ctr. Groningen, Netherlands.
Ctr. for Optical Diagnostics and Therapy, Erasmus MC, Netherlands.
J Biomed Opt. 2022 Apr;27(7). doi: 10.1117/1.JBO.27.7.074714.
The combination of reflectance and fluorescence spectroscopy allows the determination of tissue optical properties and the calculation of the intrinsic fluorescence in vivo. These parameters can discriminate between tissues and may allow the discrimination of malignant from benign tissue. While this approach has significant clinical potential, the lack of standardization and quality assessment prevents the upscaling of research.
Investigate which factors influence device calibration and tissue optical property determination. Improve system quality assessment and allow upscaling of the clinical research using multidiameter single fiber reflectance/singe fiber fluorescence spectroscopy.
Two studies, one phantom based on uniform calibrations and skin measurements and a clinical study including clinical calibrations. The first validates the effect of factors under identical conditions and the effect of calibration quality on the optical property determination of skin. The second shows the effect of different system configurations and the performance of the system and probe over an extended period.
Phantom calibrations showed stability over a period of 20 weeks except for a 16-week-old intralipid phantom which showed a significant difference (at least p = 0.0032) for all five probes evaluated. For clinical calibrations, only the fiber tree had a significant influence (probe 4: p < 0.000001 and probe 5: p = 0.00038) on the calibration quality. Interestingly, no degradation of probe performance was detected over a period of 21 months despite the exposure to stress during clinical measurements. Calibration quality affected μs' and the power law scattering exponent, but the degree of the influence was different per fiber.
Intralipid phantom quality and fiber tree performance are the main factors influencing the calibration quality. Probe and user performance did not show any effect, which makes the upscaling of research to multicenter trials easier. A high-quality assessment procedure should be implemented to track changes during clinical trials.
反射和荧光光谱学的组合允许确定组织光学性质并计算体内固有荧光。这些参数可以区分组织，并且可能允许区分恶性和良性组织。虽然这种方法具有重要的临床潜力，但缺乏标准化和质量评估阻止了研究的扩大。
研究影响设备校准和组织光学性质确定的因素。提高系统质量评估，并允许使用多直径单纤维反射/单纤维荧光光谱学扩大临床研究规模。
两项研究，一项基于均匀校准和皮肤测量的体模研究和一项包括临床校准的临床研究。第一项验证了在相同条件下因素的影响以及校准质量对皮肤光学性质确定的影响。第二项显示了不同系统配置的影响以及系统和探头在延长时间内的性能。
体模校准在 20 周内表现出稳定性，除了一个 16 周大的脂血体模外，所有五个评估的探头都显示出显著差异（至少 p<0.0032）。对于临床校准，只有光纤树对校准质量有显著影响（探头 4：p<0.000001，探头 5：p=0.00038）。有趣的是，尽管在临床测量过程中受到压力，但在 21 个月的时间内，探头性能没有检测到任何退化。校准质量影响 μs 和幂律散射指数，但每个光纤的影响程度不同。
脂血体模质量和光纤树性能是影响校准质量的主要因素。探头和用户性能没有显示任何影响，这使得研究更容易扩大到多中心试验。应实施高质量评估程序以跟踪临床试验期间的变化。
