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

Pancreatic Cancer Clinical Trial

— US-nCLE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770405
• Other study ID #: MKT_2012_nCLE_03
• Status: Completed
• Phase: N/A
• First received: January 10, 2013
• Last updated: August 28, 2017
• Start date: September 2013
• Est. completion date: December 21, 2016

Study information

• Verified date: August 2017
• Source: Mauna Kea Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• GIST
• Lymph Node Mass
• Lymphadenopathy
• Lymphatic Diseases
• Neuroendocrine Tumors
• Pancreatic Adenoma
• Pancreatic Cancer
• Pancreatic Cyst
• Pancreatic Islet Cell Tumors
• Pancreatic Neoplasms

Intervention

Device:
• Endoscopic ultrasound fine needle aspiration
Device: nCLE needle-based Confocal Laser Endomicroscopy

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Mauna Kea Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performance evaluation	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	up to one year
Secondary	Safety and feasibility evaluation	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	up to one month following the procedure