7 February 2007 Multicenter clinical trials of in vivo fluorescence: are the measurements equivalent?
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With the development of fluorescence spectroscopy, multicenter clinical trials are becoming more common both in the academic and commercial arenas. To ensure the quality of quantitative and device independent results, standardization of the tissue spectra is essential for the comparison of data from various groups. An added concern is the potential degradation of instrumentation during a trial which may affect the instrument's ability to accurately represent the tissue spectra. Our group has recently completed a Phase II clinical trial for the detection of cervical neoplasia using two different generations of spectroscopic devices at multiple sites. Both positive and negative optical standards were used to calibrate the tissue spectra as well as aid in the diagnosis of potential instrumentation problems during the trial. We have also conducted a cross validation study of fiber optic probes, spectroscopic devices, and optical standards for the latest generation of devices. The spectroscopic data of optical standards were analyzed for both the clinical trial and cross validation studies. Results demonstrated perceptible differences in optical standards data between the two generations of spectroscopy devices in the clinical trial, as well as the cross validation study with multiple devices of the same generation. Although the spectra were unexpectedly different, tissue spectra measured with the different systems can be empirically corrected by use of the various optical standards. Device performance during the clinical trial also was a concern; however, with the use of optical calibration standards, instrumentation problems were easily identified. To eliminate the problems associated with instrumentation, we have recently developed real-time quality assurance software to assess the optical calibration standards immediately after acquisition.
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Brian M. Pikkula, Brian M. Pikkula, Dan Serachitopol, Dan Serachitopol, Calum MacAulay, Calum MacAulay, Nicholas MacKinnon, Nicholas MacKinnon, Jong Soo Lee, Jong Soo Lee, Dennis Cox, Dennis Cox, E. Neely Atkinson, E. Neely Atkinson, Michele Follen, Michele Follen, Rebecca Richards-Kortum, Rebecca Richards-Kortum, "Multicenter clinical trials of in vivo fluorescence: are the measurements equivalent?", Proc. SPIE 6430, Advanced Biomedical and Clinical Diagnostic Systems V, 64301Q (7 February 2007); doi: 10.1117/12.700765; https://doi.org/10.1117/12.700765

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