Research Papers: Upper Aerodigestive CancerClinical evaluation of an autofluorescence diagnostic device for oral cancer detection: a prospective randomized diagnostic studyRana, Majeeda; Zapf, Antoniab; Kuehle, Marcoa; Gellrich, Nils-Claudiusa; Eckardt, André M.aAuthor Information Departments of aCraniomaxillofacial Surgery bInstitute for Biostatistics, Hannover Medical School, Hannover, Germany Correspondence to Majeed Rana, MD, DDS, Department of Craniomaxillofacial Surgery, Hannover Medical School, Carl-Neuberg-Street 1, D-30625 Hannover, Germany Tel: +49 511 532 4748; fax: +49 511 532 4740; e-mail: [email protected] Received September 16, 2011 Accepted November 30, 2011 European Journal of Cancer Prevention: September 2012 - Volume 21 - Issue 5 - p 460-466 doi: 10.1097/CEJ.0b013e32834fdb6d Buy Metrics Abstract The prognosis for patients with oral squamous cell carcinoma remains poor despite advances in multimodal treatment concepts. Early diagnosis and treatment is the key to improved patient survival. A device (VELscope) that uses autofluorescence technology, allowing direct fluorescence visualization of the oral cavity, might be a useful tool for oral cancer detection or as an adjunct to standard clinical examination. A total of 289 patients with oral premalignant lesions were randomly divided into two groups for clinical examination of precancerous oral lesions. In group 1, 166 patients were examined conventionally with white light, and in group 2, 123 patients were examined with the autofluorescence visualization device (VELscope) in addition to the white light examination. Biopsies were obtained from all suspicious areas identified in both examination groups (n=52). In the first step, baseline characteristics of the two groups (only white light vs. white light and VELscope) were compared to exclude selection bias. In the second step, for the group examined with white light and VELscope (123 patients), the diagnostic strategies were compared with regard to sensitivity and specificity using biopsy as the gold standard. The results showed that using the VELscope leads to higher sensitivity (100% instead of 17%), but to lower specificity (74% instead of 97%). Thus, we can conclude that the VELscope is a useful new diagnostic device for detection of oral cancer diseases. © 2012 Lippincott Williams & Wilkins, Inc.