Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

Status:	Completed
Conditions:	Cancer, Cancer, Cancer, Brain Cancer, Lymphoma, Endocrine, Pancreatic Cancer
Therapuetic Areas:	Endocrinology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	8/30/2017
Start Date:	September 2013
End Date:	December 21, 2016

Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

This study focuses on four different lesions: pancreatic cysts, lymph nodes near the
gastrointestinal tract, pancreatic masses and GIST tumors.

On one hand, the results obtained during previous studies are more advanced for the
assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser
Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have
already been performed, and an interpretation criteria classification exists. On the other
hand, results for pancreatic masses, Lymph nodes and GIST are less developed.

the objectives of the study are to

- Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser
Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas,
lymph nodes, submucosal lesions of the GI tract

- Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of
the pancreas, lymph nodes, submucosal lesions of the GI tract

The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within
or adjacent to the GI or respiratory tracts by means of a miniprobe inserted through an
endoscopic needle. The fundamental technology, as well as the principle of operation of nCLE,
is substantially similar to pCLE.

endoscopic fine needles are used during EUS-FNA procedures to puncture solid organs such as
the pancreas, in order to get tissue or fluid for diagnostic purposes. There are different
calibers of endoscopic nee-dles used. The most commonly used calibers for EUS-FNA procedures
are 22G, 19G, and 25G needles. The nCLE Confocal Miniprobe is compatible with the 19G-type
needle only. It is expected to help to differentiate the different types of lesions,
especially for cysts, leading to better patient management. Microscopic tissue information in
real-time in vivo during an EUS-FNA procedure may allow better differentiation between
mucinous and non-mucinous cysts for instance.

Inclusion Criteria:

- - Male or female > 18 years of age

- Patient indicated for a first EUS-FNA for masses and cystic tumors of the pancreas,
lymph nodes, submu-cosal lesions of the GI tract

- Patients who had previous non-diagnostic tissue sampling taken during a previous
EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions
of the GI tract

- Patient with known masses and cystic tumors of the pancreas, lymph nodes, submucosal
lesions of the GI tract

- For pancreatic cyst patient, suffering chronic calcifying pancreatitis

- For pancreatic mass patient, any size or location

- For lymph node patient, any node reachable with EUS-FNA

- Willing and able to comply with study procedures and provide written informed consent
to participate in the registry

Exclusion Criteria:

- - Subjects for whom EUS-FNA procedures are contraindicated

- Known allergy to fluorescein contrast

- If female, breast feeding or pregnant based on a positive hCG serum or an in vitro
diagnostic test result

- Subject with multiple cysts

- Cysts <20 mm in diameter

- Previous EUS-FNA procedure performed less than 3 months ago

- If several pancreatic masses, only one will be imaged during the nCLE procedure

- Lymph nodes <5 mm in diameter

- If several suspicious lymph nodes, only the most suspect will be imaged during the
nCLE proce-dure

We found this trial at

sites

Emory University Hospital

1364 Clifton Rd NE
Atlanta, Georgia 30322

(404) 712-2000