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
Cellvizio and double-balloon enteroscopy
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.”
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
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.
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.
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
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