0
Research Papers

Fluorescence and reflectance device variability throughout the progression of a phase II clinical trial to detect and screen for cervical neoplasia using a fiber optic probe

[+] Author Affiliations
Nick McKinnon

British Columbia Cancer Research Center, Department of Cancer Imaging, 601 West 10th Avenue, Vancouver, British Columbia V5Z 1L3, Canada

Roderick Price

The University of Texas, M. D. Anderson Cancer Center, Biomedical Engineering Center, 1515 Holocombe Boulevard, Box 193, Houston, Texas 77030

E. Neely Atkinson

The University of Texas, M. D. Anderson Cancer Center, The Department of Biostatistics, Houston, Texas 77030

Dennis D. Cox

Rice University, Department of Statistics, P.O. Box 1892, Houston, Texas 77005

Calum MacAulay

British Columbia Cancer Research Center, Department of Cancer Imaging, 601 West 10th Avenue, Vancouver, British Columbia V5Z 1L3, Canada

Rebecca Richards-Kortum

Rice University, Department of Bioengineering, P.O. Box 1892, Houston, Texas 77005

Michele Follen

The University of Texas, M. D. Anderson Cancer Center, Biomedical Engineering Center and Department of Gynecologic Oncology, Center for Biomedical Engineering, 1515 Holcombe Boulevard, Box 193, Houston, Texas 77030 and The University of Texas, Health Science Center at Houston, Department of Obstetrics, Gynecology, and Reproductive Sciences, Houston, Texas 77030

Brian Pikkula

The University of Texas, M. D. Anderson Cancer Center, Biomedical Engineering Center, 1515 Holcombe Boulevard, Box 193, Houston, Texas 77030

J. Adrian Freeberg, Dan M. Serachitopol

The University of Texas, M. D. Anderson Cancer Center, Biomedical Engineering Center, 1515 Holocombe Boulevard, Box 193, Houston, Texas 77030

J. Biomed. Opt. 12(3), 034015 (June 28, 2007). doi:10.1117/1.2750332
History: Received November 08, 2006; Revised February 09, 2007; Accepted February 10, 2007; Published June 28, 2007
Text Size: A A A

Large phase II trials of fluorescence and reflectance spectroscopy using a fiber optic probe in the screening and diagnostic settings for detecting cervical neoplasia have been conducted. We present accrual and histopathology data, instrumentation, data processing, and the preliminary results of interdevice consistencies throughout the progression of a trial. Patients were recruited for either a screening trial (no history of abnormal Papanicolaou smears) or a diagnostic trial (a history of abnormal Papanicolaou smears). Colposcopy identified normal and abnormal squamous, columnar, and transformation zone areas that were subsequently measured with the fiber probe and biopsied. In the course of the clinical trial, two generations of spectrometers (FastEEM2 and FastEEM3) were designed and utilized as optical instrumentation for in vivo spectroscopic fluorescence and reflectance measurements. Data processing of fluorescence and reflectance data is explained in detail and a preliminary analysis of the variability across each device and probe combination is explored. One thousand patients were recruited in the screening trial and 850 patients were recruited in the diagnostic trial. Three clinical sites attracted a diverse range of patients of different ages, ethnicities, and menopausal status. The fully processed results clearly show that consistencies exist across all device and probe combinations throughout the diagnostic trial. Based on the stratification of the data, the results also show identifiable differences in mean intensity between normal and high-grade tissue diagnosis, pre- and postmenopausal status, and squamous and columnar tissue type. The mean intensity values of stratified data show consistent separation across each ofthe device and probe combinations. By analyzing trial spectra, we provide more evidence that biographical variables such as menopausal status as well as tissue type and diagnosis significantly affect the data. Understanding these effects will lead to better modeling parameters when analyzing the performance of fluorescence and reflectance spectroscopy.

Figures in this Article
© 2007 Society of Photo-Optical Instrumentation Engineers

Citation

Nick McKinnon ; Roderick Price ; E. Neely Atkinson ; Dennis D. Cox ; Calum MacAulay, et al.
"Fluorescence and reflectance device variability throughout the progression of a phase II clinical trial to detect and screen for cervical neoplasia using a fiber optic probe", J. Biomed. Opt. 12(3), 034015 (June 28, 2007). ; http://dx.doi.org/10.1117/1.2750332


Access This Article
Sign In to Access Full Content
Please Wait... Processing your request... Please Wait.
Sign in or Create a personal account to Buy this article ($20 for members, $25 for non-members).
 
Your Session has timed out. Please sign back in to continue.
Sign In to Access Full Content

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Related Book Chapters

Topic Collections

Advertisement

Buy this article ($18 for members, $25 for non-members).
Sign In