NEW ORLEANS, May 6, 2010 (GLOBE NEWSWIRE) -- Data from an international, multi-center randomized controlled study show that using Mauna Kea Technologies' Cellvizio® system to examine Barrett's esophagus tissue at the cellular level during endoscopy procedures significantly improves a physician's ability to accurately detect early esophageal cancer and dysplastic changes compared to standard imaging methods alone. The data also showed that the probe-based confocal laser endomicroscopy (pCLE) system allows physicians to confirm the absence of disease with strong accuracy, so they can avoid removing healthy tissue to reduce costs and complications to the patient.
Lead investigator Prof. Prateek Sharma, M.D., presented the final results of the "DONT BIOPCE" (Detection of Neoplastic Tissue in Barrett's Esophagus with In vivo Probe-based Confocal Endomicroscopy), study today in an oral presentation (Abstract #1071) at Digestive Disease Week 2010, which took place from May 1-5.
"These results demonstrate that endomicroscopic imaging could lead to an important paradigm shift in how physicians monitor for and treat early esophageal cancer and high grade dysplasia in patients with Barrett's esophagus," said Dr. Sharma, who is Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of Kansas School of Medicine and the VA Medical Center in Kansas City, MO. "Armed with the cellular-level information that pCLE provides, we can more precisely characterize mucosal changes in the esophagus and detect more cancerous and pre-cancerous lesions in more areas and patients. The information that pCLE provides allows us to make more informed treatment decisions on the spot. We can also rule out disease with high accuracy, which will help us significantly reduce the number of random biopsies and the costs associated with the current practice."
The study showed that neither white-light endoscopy nor narrow-band imaging on their own or in combination was able to detect all pre-cancerous and cancerous lesions during Barrett's esophagus surveillance. By adding pCLE to narrow band imaging or white light endoscopy exams, physicians were able to identify all patients in the study with high-grade dysplasia or early esophageal cancer.
The study also showed that patients who tested negative under all three modalities – white light endoscopy, narrow band imaging and pCLE – could forego the tedious random biopsy process. In the study population, which typically has a higher prevalence of cancer than the mix of patients seen at community hospitals, the negative predictive value (the proportion of patients with a positive test who are correctly diagnosed) of pCLE was 95.6%. These findings correlate with results from an earlier study that showed that pCLE generated a negative predictive value of 98.8% when conducted on a lower prevalence population (Pohl et al, Gut 2008). Based on the findings in the DONT BIOPCE study, 39% of patients could have foregone biopsies altogether, saving more than 330 biopsies out of 874 (37.8%), which could translate to a potential reduction in costs.
Five centers in the U.S. (V.A. Kansas City, Mayo Clinic Jacksonville, Columbia Presbyterian) and Europe (Klinikum Rechts der Isar, Munich, University Hospital, Nantes) enrolled 101 patients with Barrett's esophagus (mean age 65.1 yrs; 86% men) into the study.
Using standard endoscopes with either white light endoscopy or narrow band imaging, physicians identified suspicious lesions and also took random four-quadrant biopsies, as defined by existing guidelines, for a total of 874 tissue samples. Pathology results confirmed 146 of the 874 total tissue samples to be early forms of esophageal cancer.
When adding Cellvizio to white light endoscopy, 41 additional pre-cancerous or cancerous lesions were identified than with white light endoscopy alone. Likewise, when adding Cellvizio to white light endoscopy or narrow band imaging, doctors found 37 additional malignant sites.
A separate study (Abstract 1074) presented by Dr. Sharma's team from the University of Kansas and VA Medical Center in Kansas City showed that after only an hour of structured teaching, novice users were able to correctly differentiate pre-cancerous from non-cancerous Barrett's tissue as well as the expert Cellvizio users when viewing pCLE videos captured during the DONT BIOPCE study.
Based on the positive results of the "DONT BIOPCE study," the company recently started enrolling patients in a large, randomized, controlled, multi-center outcomes study to confirm that Cellvizio helps physicians identify pre-cancerous tissue that may have been missed during therapeutic interventional procedures for Barrett's esophagus. For more information on the study, known as CLEAN MARGIN, please visit ClinicalTrials.gov.
About Barrett's Esophagus
Barrett's Esophagus occurs when gastroesophageal reflux disease causes stomach acid to leak back into the esophagus and damage the lining. This can increase the risk of cancer of the esophagus (adenocarcinoma), the symptoms of which can be difficulty swallowing or weight loss. Since the 1980s, incidence rates of adenocarcinoma of esophagus (ACE) have been increasing in both genders in developed countries. ACE is the fastest rising malignancy among white men in the United States, with a relative increase even higher than that observed for breast cancer, malignant melanoma, or prostate cancer. From 1975 to 2001, the incidence of ACE increased sixfold in the United States, from 4 to 23 cases per million (Journal of the National Cancer Institute 2005;97:142-146).
About DDW
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 1-5, 2010, at the Ernest N. Morial Convention Center, New Orleans, LA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
About Cellvizio
Cellvizio, the world's smallest and most flexible microscope, is the first system designed to provide real time live images of internal human tissues at the cellular level during endoscopic procedures. This new method, known as probe-based Confocal Laser Endomicroscopy (pCLE), allows physicians to visualize an area of interest and use this information in the overall assessment of the patient's condition, which may aid in real-time treatment decisions. This new, advanced imaging technique helps physicians to detect abnormalities more effectively so patients may be treated earlier and may undergo fewer endoscopic procedures. Physicians and thought leaders at almost 100 top medical institutions around the world have completed over 4,000 of these procedures and have published more than 35 peer-reviewed papers on the technology in major medical journals. Cellvizio, which delivers up to 12 microscopic images per second and can be used with almost any endoscope, has premarket notification 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI and pulmonary tracts.
About Mauna Kea Technologies
Mauna Kea Technologies (DDW Booth #547) is a medical device company based in Paris, France. With its flagship Cellvizio systems, the company leads the growing endomicroscopy imaging market, enabling physicians to visualize, diagnose and treat directly inside the body in real time, pathologies that may not be seen using other imaging techniques. Investors include Psilos Group, Seventure and Creadev. For more information about Mauna Kea Technologies visit www.maunakeatech.com.