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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mauna Kea Technologies
Sponsor:
Information provided by (Responsible Party):
Mauna Kea Technologies
ClinicalTrials.gov Identifier:
NCT01770405
First received: January 10, 2013
Last updated: May 16, 2014
Last verified: May 2014
History of Changes
  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:

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: September 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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
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 Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kevin Woods, MD    404-712-2000    kevin.woods@emory.edu   
Principal Investigator: Kevin Woods, MD         
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 North Shore-LIJ Health System
  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: May 16, 2014
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:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
 Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on March 03, 2015