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

Purpose

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


Study Type:	Observational [Patient Registry]
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Pancreatic Cancer

Genetic and Rare Diseases Information Center resources: Pancreatic Neuroendocrine Tumor Pancreatic Islet Cell Tumors Pancreatic Adenoma Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Mauna Kea Technologies:

Primary Outcome Measures:

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:

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


Estimated Enrollment:	70
Study Start Date:	September 2013
Estimated Study Completion Date:	October 2016
Estimated Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770405

Contacts


Contact: Divyesh V Sejpal, MD	516-562-4281	Dsejpal@NSHS.edu

Locations


United States, Georgia
Emory University Hospital	Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, New York
North Shore-LIJ Health System	Recruiting
Manhasset, New York, United States, 11030
Contact: Divyesh V Sejpal, MD 516-562-4281 Dsejpal@NSHS.edu
Principal Investigator: Divyesh Sejpal, MD
Columbia University Medical Center	Not yet recruiting
New York, New York, United States, 10032
Contact: Frank Gress, MD 212-305-1909 fgg2109@cumc.columbia.edu
Principal Investigator: Frank G Gress, MD
United States, Pennsylvania
Temple University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Oleh Haluszka, MD Oleh.Haluszka@tuhs.temple.edu
Principal Investigator: Oleh Haluszka, MD

Sponsors and Collaborators

Mauna Kea Technologies

Investigators


Principal Investigator:	Divyesh V Sejpal, MD	Northwell Health

More Information


Responsible Party:	Mauna Kea Technologies
ClinicalTrials.gov Identifier:	NCT01770405 History of Changes
Other Study ID Numbers:	MKT_2012_nCLE_03
Study First Received:	January 10, 2013
Last Updated:	August 29, 2016

Keywords provided by Mauna Kea Technologies:


endomicroscopy needle-based pancreatic	cyst mass EUSFNA

Additional relevant MeSH terms:


Pancreatic Neoplasms Adenoma Lymphatic Diseases 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 Cysts Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Pancrelipase Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 27, 2017

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