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

Completed

Conditions studied: Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer, Pancreatic Islet Cell Tumors, Lymph Node Mass, Lymphadenopathy, GIST

In brief

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

Key facts

Study ID

NCT01770405

Run by

Mauna Kea Technologies

People needed

40

Starts

2013-09-01

Expected to finish

2016-12-21

Last updated by the study team

2017-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• - 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

You may not qualify if…

• - 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

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States
• North Shore-LIJ Health System — Manhasset, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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