New data presented at Digestive Disease Week® (DDW®) 2013 suggests optical biopsies using a microscope so tiny it fits through a needle, could assist physicians in the diagnosis of pancreatic cystic tumors and help patients with benign cysts avoid unnecessary surgery.
Background
Mauna Kea Technologies is a leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cellular-level images inside pancreatic cysts. The company researches, develops and markets innovative tools to visualize and detect cellular abnormalities during endoscopic procedures. Mauna Kea’s flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multicenter clinical trials have already demonstrated Cellvizio’s ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately.
According to new study data, presented at this year’s DDW meeting, images from the CONTACT 1 study led by Bertrand Napoleon, MD, from the Hôpital Jean Mermoz in Lyon, France and colleagues were able to identify superficial vascular networking (SVN) as a key feature of a specific sub-type of pancreatic cyst (serous cystadenoma) that is always considered to be benign. According to their analysis of 18 patients with pancreatic cysts larger than 2cm, needle-based optical biopsies generated specificity and positive predictive value of 100% in identifying SVN. They also found that optical biopsy images are easy to interpret with these criteria and that after limited training, both novice and expert endoscopists can agree on a diagnosis based on the images.
Physician comments
“With current imaging and sampling techniques, it remains difficult to accurately rule out malignant or pre-malignant pancreatic cystic tumors, so certain patients have to undergo surgery before a diagnosis can be confirmed,” said Marc Giovannini, MD, Head of the Endoscopy Unit at Paoli-Calmettes Institute in Marseille, France. “This can have dramatic implications for these patients, especially when we find out the cyst was benign. This new data shows that needle-based optical biopsies may provide the missing information needed to separate high-risk and low-risk cysts. In my practice, I already see a significant impact on the management of patients with pancreatic cysts.”
“Real time optical biopsies have helped us identify a key feature of this kind of benign cyst,” Dr. Napoleon said. “With this new information, we should be able to help patients with serous cystadenomas avoid unnecessary surgery. We look forward to prospectively validating these results and believe this new information could have a significant impact on patient care.”
Company comments
“We have dedicated ourselves to bringing microscopic imaging into parts of the body where it was never feasible before so patients can receive diagnoses faster — and get the right treatment,” said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. “We’re very proud of the innovation behind the AQ-Flex miniprobe and of the results presented at DDW 2013. We look forward to continuing to work with experts around the globe to confirm these exciting results.”
Reference: Napoleon, MD, Bertrand, “In Vivo Characterization of Pancreatic Serous Cystadenomas by Needle-Based Confocal LASER Endomicrosopy (nCLE). Intra and Inter Observer Agreement – Contact Study,” DDW 2013, Orlando, Abstract Tu1226
Source: Mauna Kea Technologies, Market Wired
published: May 23, 2013 in: Clinical Studies/Trials, Congresses and Meetings, Endoscopy, Imaging