TINY INTERNAL MICROSCOPE RULES OUT ESOPHAGEAL EARLEY CANCER.

Physicians can easily rule out early esophageal cancer by adding Cellvizio, the world's most miniaturized microscope, to standard upper endoscopy procedures, according to data presented here Tuesday during a Distinguished Oral Presentation (#854) at Digestive Disease Week(r) (DDW) 2009. A separate pilot study (Abstract W1362) presented at DDW further confirmed these results and found that different users draw very similar conclusions when interpreting Cellvizio video sequences.

"Cellvizio's sharp, real-time, microscopic image sequences of the GI tract allow us to avoid taking biopsies of normal esophageal tissue, saving time, costs and reducing risk of biopsy-related complications when monitoring patients with Barrett's esophagus," said Alexander Meining, MD, Associate Professor of Medicine, Department of Medicine II, Technical University of Munich. "Cellvizio should lead to a shift away from the current random biopsy practice."

Barrett's esophagus is a condition of the esophagus usually resulting from prolonged gastroesophageal reflux disease (GERD) that potentially leads to esophageal cancer, the fastest growing cancer in the U.S. However, standard endoscopic imaging modalities fail to differentiate the pre-cancerous from benign tissue in the Barrett's segment, so physicians take random biopsies (as many as a few dozen per patient) in hopes that it represents an accurate sample.

In the multi-center study led by Dr. Meining, physicians used Cellvizio to capture video sequences of around 700 randomly-selected areas in the esophagi of 68 patients with Barrett's esophagus and recorded their interpretation of the images. They then removed tissue at those exact sites and sent it to the lab for analysis. Of the 703 biopsies that were sent out, only 59 or 8.4% were confirmed to be cancerous or pre-cancerous; 644 were deemed normal.

In the on-site analysis, Cellvizio generated specificity or a true negative rate of 95% and a 92% negative predictive value, meaning that there's a 92% chance that the target tissue deemed normal with Cellvizio was in fact normal. The Cellvizio images were sent to a different physician for a blinded analysis, who generated 90% specificity and 96% negative predictive value when viewing the image sequences.

"Had the physicians used the Cellvizio cellular-level images to guide their biopsy decisions, they would have been able to dramatically decrease the number of tissue samples they removed from these patients," Meining said. "Given these findings, Cellvizio should be used to enable more efficient biopsy practices, which will ultimately improve patient care and significantly reduce lab costs and time associated with analyzing normal tissue."

Michael B. Wallace, M.D., Director of Research for the Department of Medicine and the Division of Gastroenterology and Hepatology at Mayo Clinic, Jacksonville, presented data from the separate pilot study conducted at Mayo Jacksonville, Columbia-Presbyterian Hospital in New York, the Veterans Affairs Hospital in Kansas City, Mo., and Dr. Meining's site in Munich. This study was designed to determine physicians' ability to diagnose malignancy in the esophagus as well as rule it out with Cellvizio images -- and to measure how well they agreed on Cellvizio image interpretation.