Submitted for Publication: March 8, 2011; final revision received August 9, 2011; accepted September 4, 2011.
Author Contributions: Drs Shafirstein and Suen are considered the principal investigators of this study. Dr Shafirstein had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Shafirstein, Bäumler, Vural, Stack, and Suen. Acquisition of data: Shafirstein, Fan, Morehead, Vural, and Suen. Analysis and interpretation of data: Shafirstein, Friedman, Siegel, Moreno, and Suen. Drafting of the manuscript: Shafirstein and Suen. Critical revision of the manuscript for important intellectual content: Shafirstein, Friedman, Siegel, Moreno, Bäumler, Fan, Morehead, Vural, Stack, and Suen. Statistical analysis: Siegel. Obtained funding: Shafirstein. Administrative, technical, and material support: Shafirstein, Fan, Morehead, Vural, Stack, and Suen. Study supervision: Shafirstein, Bäumler, Fan, and Suen.
Financial Disclosure: None reported.
Funding/Support: DUSA Pharmaceuticals, Inc, Valhalla, New York, provided the 5-ALA (Levulan Kerastick) at no cost, and Biocam GmbH, Regensburg, Germany, provided the fluorescence diagnosis imaging system at no cost.
Previous Presentation: This study was presented at the American Head and Neck Society 2011 Annual Meeting; April 28, 2011; Chicago, Illinois.
Additional Contributions: Linda Wood, RN, BSN, CCRP, and Karen DuVall, BS, CCRP, assisted with the study coordination. Scott Ferguson assisted with the laser setup. We thank all the personnel at the University of Arkansas for Medical Sciences research support center for their outstanding help in obtaining the approval for the investigational new drug No. 73269 and monitoring the study. We acknowledge the support of the Otolaryngology Department through the McGill Family Division of Clinical Research.