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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment
Pancreatic Cyst; Pancreatic Neoplasms; Pancreatic Adenoma; Pancreatic Cancer; Pancreatic Islet Cell Tumors; Lymph Node Mass; Lymphadenopathy; GIST	Device: Endoscopic ultrasound fine needle aspiration

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 Design

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Study Type :	Observational [Patient Registry]
Actual Enrollment :	40 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	1 Year
Official Title:	Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
Study Start Date :	September 2013
Actual Primary Completion Date :	December 21, 2016
Actual Study Completion Date :	December 21, 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
pancreatic cysts; Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,	Device: Endoscopic ultrasound fine needle aspiration; Device: nCLE needle-based Confocal Laser Endomicroscopy; Other Names: ultrasonographic endoscopy; EUS-guided FNA

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. performance evaluation [ Time Frame: 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 :

1. Safety and feasibility evaluation [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Referral patients with a clinical indication for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract coming in for first EUS-FNA procedure at referral institution will be approached for possible inclusion into this registry

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, New York
North Shore-LIJ Health System
Manhasset, New York, United States, 11030
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

Mauna Kea Technologies

Investigators

Principal Investigator:	Divyesh V Sejpal, MD	Northwell Health

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mauna Kea Technologies
ClinicalTrials.gov Identifier:	NCT01770405 History of Changes
Other Study ID Numbers:	MKT_2012_nCLE_03
First Posted:	January 17, 2013
Last Update Posted:	August 29, 2017
Last Verified:	August 2017

Keywords provided by Mauna Kea Technologies:

endomicroscopy; needle-based; pancreatic	cyst; mass; EUSFNA

Additional relevant MeSH terms:

Pancreatic Neoplasms; Adenoma; Lymphadenopathy; Pancreatic Cyst; Adenoma, Islet Cell; Neuroendocrine Tumors; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases	Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Lymphatic Diseases; Cysts; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancrelipase; Gastrointestinal Agents