Registry Trial for Clinical Evaluation 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 Lymphadenopathy GIST	Device: EUS-FNA: Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle

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: Benign Tumors Cancer Endoscopy Pancreatic Cancer

Drug Information available for: Pancreatin Pancrelipase

U.S. FDA Resources

Further study details as provided by Mauna Kea Technologies:

Primary Outcome Measures:

performance evaluation [ Time Frame: up to one year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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:	February 2013
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
pancreatic cysts Patient indicated for a first EUS-FNA for a pancreatic cyst,	Device: EUS-FNA: Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle Device: nCLE needle-based Confocal Laser Endomicroscopy Other Names: Other Names: ultrasonographic endoscopy EUS-guided FNA Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
pancreatic mass Patient indicated for a first EUS-FNA for a pancreatic mass	Device: EUS-FNA: Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle Device: nCLE needle-based Confocal Laser Endomicroscopy Other Names: Other Names: ultrasonographic endoscopy EUS-guided FNA Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
lymph node Patient indicated for a first EUS-FNA for a lymph node	Device: EUS-FNA: Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle Device: nCLE needle-based Confocal Laser Endomicroscopy Other Names: Other Names: ultrasonographic endoscopy EUS-guided FNA Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
GIST Patient indicated for a first EUS-FNA for a GIST	Device: EUS-FNA: Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle Device: nCLE needle-based Confocal Laser Endomicroscopy Other Names: Other Names: ultrasonographic endoscopy EUS-guided FNA Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle

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
Genders Eligible for Study:	Both
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

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

Contacts

Contact: Divyesh Sejpal, MD

713-798-5935

sejpal@bcm.edu

Locations

United States, Georgia
Emory University Hospital	Not yet recruiting
Atlanta, Georgia, United States
Contact: kevin Woods, MD 404-712-2000 kevin.woods@emory.edu
United States, New York
SUNY Downstate Medical Center, New york	Not yet recruiting
New york city, New York, United States, 11226
Contact: Frank Gress, MD 718-282-7234 ext 001 frank.gress@downstate.edu
United States, Pennsylvania
Temple University Hospital	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Oleh Haluszka, MD Oleh.Haluszka@tuhs.temple.edu
United States, South Dakota
Sanford USD Medical Center	Not yet recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Muslim Atiq, MD 605-610-7704 muslim.atiq@sanfordhealth.org
United States, Texas
Baylor College of Medicine	Not yet recruiting
Houston, Texas, United States, 77030
Contact: divyesh Sejpal, MD 713-798-5935 sejpal@bcm.edu
Principal Investigator: Divyesh Sejpal, MD

Sponsors and Collaborators

Mauna Kea Technologies

Investigators

Principal Investigator:

Divyesh Sejpal, MD

Baylor college of medicine, Houston

More Information

No publications provided

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:	January 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mauna Kea Technologies:

endomicroscopy
needle-based
pancreatic

cyst
mass
EUSFNA

Additional relevant MeSH terms:

Adenoma
Neoplasms
Pancreatic Cyst
Pancreatic Neoplasms
Adenoma, Islet Cell
Lymphatic Diseases
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cysts
Pancreatic Diseases
Digestive System Diseases

Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013