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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Cyst Adenoma Adenoma, Islet Cell Arachnodactyly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases GIST Hemic and Lymphatic Diseases Limb Deformities, Congenital Lymph Node Mass Lymphadenopathy Lymphatic Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Adenoma Pancreatic Cancer Pancreatic Diseases Pancreatic Islet Cell Tumors Pancreatic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University Hospital, Atlanta, Georgia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic ultrasound fine needle aspiration

Device

Device: nCLE needle-based Confocal Laser Endomicroscopy

Other names: ultrasonographic endoscopy, EUS-guided FNA

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Mauna Kea Technologies

Industry

Registry information

Official study title

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

Acronym: US-nCLE

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Jan 17, 2013
Registry last updated: Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting