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

Completed

• Conditions: Pancreatic Neoplasms; Pancreatic Cancer; Lymph Node Mass; Pancreatic Cyst; Lymphadenopathy; GIST; Pancreatic Adenoma; Pancreatic Islet Cell Tumors
• Interventions: Device: Endoscopic ultrasound fine needle aspiration

• Registration Number: NCT01770405
• Lead Sponsor: Mauna Kea Technologies

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Study Start: 2013-09
• Primary Completion: 2016-12-21
• Study Completion: 2016-12-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pancreatic cysts	Endoscopic ultrasound fine needle aspiration	Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,

Primary Outcome Measures

Name	Time	Method
performance evaluation	up to one year	* 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 (accuracy evaluation); * Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition

Secondary Outcome Measures

Name	Time	Method
Safety and feasibility evaluation	up to one month following the procedure	* Evaluate the feasibility and safety of nCLE for the characterization of masses and cystic tumors of the pan-creas, lymph nodes, submucosal lesions of the GI tract (IE. number of patients with complications, number of adverse events); * Build an atlas of images of nCLE sequences of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract

Trial Locations

Locations (4)

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