Diagnostic imaging

New clinical studies confirm Mauna Kea Technologies’ endomicroscopy system in a range of procedures

23 November 2007

Mauna Kea Technologies (MKT), a supplier of in vivo cellular imaging systems, has reported on studies related to the company’s Cellvizio GI system by leading European gastroenterologists presented at the 15th United European Gastroenterology Week (UEGW).

The reported data demonstrate the clinical utility of Cellvizio GI during double-balloon enteroscopy (DBE) as well as in the diagnosis of a range of gastrointestinal (GI) disorders. The findings also provide insight into criteria for optimizing Cellvizio GI performance.

MKT claims the Cellvizio GI is the first and only confocal endomicroscopy instrument that is compatible with all endoscopes and allows real-time, dynamic microscopic imaging of the entire GI tract at 12 frames per second. To date, more than 600 patients have undergone an endoscopic procedure with the Cellvizio GI imaging system.

Cellvizio and double-balloon enteroscopy

In an oral presentation (Abstract FP-337), Pr. Stephan Miehlke, University Hospital, Dresden, Germany, described the first use of the Cellvizio GI system with DBE to evaluate the entire small bowel in 27 procedures in 16 patients. It obtained informative images in all procedures but one, yielding a technical success rate of 96%. There were no adverse events related to DBE or the use of Cellvizio. The system was able to detect both normal and abnormal villi throughout the GI tract. All the GI results were confirmed by subsequent histology of biopsy samples.

“The ability to use Cellvizio GI with DBE provides a powerful new approach to evaluate the entire small bowel at the cellular level without the need for taking biopsy samples,” said Dr. Miehlke. “This reduces the potential for adverse events associated with biopsy procedures while providing rapid and accurate findings that can help to optimize patient care. Further evaluation of the Cellvizio GI system with DBE is warranted in order to understand how to best apply this powerful imaging approach across a variety of known or suspected GI disorders.”

Three other clinical studies describing positive preliminary results using Cellvizio GI to diagnose GI Graft-versus-Host disease (GI-GVHD), biliary strictures and celiac sprue were presented in poster sessions. Sacha Loiseau, Ph.D. president and CEO of Mauna Kea Technologies, said, “These preliminary studies provide a solid foundation on which we will advance the evaluation of Cellvizio GI in a growing range of gastroenterology procedures. We believe that these data demonstrate the importance of the Cellvizio GI system as a novel, non-invasive imaging and analysis tool that has the potential to transform and improve the care and treatment of patients with known or suspected GI pathology.”

Additional clinical data

Abstract PS-W-23 described preliminary results of a study evaluating Cellvizio GI in diagnosing GI-GVHD, a frequent and often life-threatening complication of allogeneic hematopoetic stem cell transplant. To date, four procedures have been conducted in three patients. In all four procedures, Cellvizio GI findings have been confirmed by histology, including three positive findings of GI-GVHD and one finding of normal villi architecture.

These preliminary results are quite promising, especially given that the gold standard for diagnosing GI-GVHD is histology based on multiple biopsies. Moreover, the correlation between conventional endoscopy and histology in this disease is poor. Based on these promising findings, a prospective blinded study has been initiated to evaluate and define criteria for use of Cellvizio GI in diagnosing GI-GVHD.

Promising results were reported in a study evaluating Cellvizio GI in the differential diagnosis of indeterminate biliary strictures (Abstract PS-W-24). Standard approaches to making this differential diagnosis have certain limitations, which may be overcome by Cellvizio GI. In 7 patients, the Cellvizio probe was introduced directly into the common bile duct.

In a further 7 patients, the further miniaturized probe was introduced and placed to suspected lesions under visual control via a cholangioscope. The probe could be introduced in all patients, and imaging of the cellular structures of the bile duct epithelium was possible in all cases.

In two patients in whom the probe was inserted directly, the probe could not be inserted far enough to reach the stenosis and corresponding histology samples were unable to be obtained in these cases. No side effects were observed. Cellvizio GI revealed normal findings in benign cases. Biliary cancers showed features of thickened vessels with black cells in 5 of 6 cases of malignancy. Investigators conclude that Cellvizio GI enables imaging of cellular details even in small ducts such as in the biliary system.

The system has the potential to increase the diagnostic accuracy for further differentiation of strictures and stenosis, which is one of the most poorly diagnosed GI conditions and can lead to cancers with the poorest prognosis: cholangiocarcinoma or pancreatic cancer.

Another study evaluated the ability of Cellvizio GI to evaluate pathologic features of small intestinal pathology (Abstract PS-M-08). The study examined 20 patients with known celiac sprue and well controlled disease. Biopsies were taken from areas evaluated with Cellvizio GI to allow precise comparison with histology findings.

A total of 80 GI sites were evaluated. Seven patients had pathological findings consistent with celiac disease, two of which were classified as Marsh III. Image quality was sufficient to allow evaluation of morphological characteristics in 93% of sites; resolution was sufficient in 91%. Epithelial width could be measured in 94% and villous width in 88%. Epithelial cell cytoplasm and basal cell layer regularity could only be assessed in 30% and 26%, respectively. Investigators conclude that Cellvizio GI can identify histological details critical for the detection of hallmark features of intestinal pathology in celiac patients.

Physicians from Klinikum rechts der Isar in Munich, Germany presented results from a preclinical study that investigated the optimal timing for use of Cellvizio GI imaging with intravenous fluorescein in a pig model in a poster (Abstract PS-W-22). Results demonstrate that fluorescein-enhanced imaging of the gastrointestinal tract with Cellvizio delivers best contrast and image quality one to eight minutes after fluorescein injection, with best resolution after five minutes. The authors conclude that these data may facilitate development of standardized protocols for utilizing Cellvizio GI in clinical practice. Standard protocols are expected to facilitate more widespread adoption and appropriate application of this innovative imaging technology.

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