Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas (CONTACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Mauna Kea Technologies
Sponsor:
Information provided by (Responsible Party):
Mauna Kea Technologies
ClinicalTrials.gov Identifier:
NCT01563133
First received: March 22, 2012
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses.

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 and Lymph nodes are less developed.

The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes.

  1. Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making.

    For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :

    • Ruling out malignancy for patients with benign appearing nCLE images.
    • Characterizing more malignant tumors in the pancreas.
  2. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.

Condition Intervention Phase
Pancreatic Cyst
Pancreatic Neoplasms
Pancreatic Adenoma
Pancreatic Cancer
Pancreatic Islet Cell Tumors
Lymph Node
Lymphadenopathy
Procedure: EUS-FNA
Device: nCLE
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas

Resource links provided by NLM:


Further study details as provided by Mauna Kea Technologies:

Primary Outcome Measures:
  • Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts [ Time Frame: Within 6 months after the end of Follow-up period ] [ Designated as safety issue: No ]
  • Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes [ Time Frame: Within one year after the end of the follow-up period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst [ Time Frame: Within one year after the end of the follow-up period ] [ Designated as safety issue: No ]
  • Validation of the interpretation criteria classification for pancreatic cysts [ Time Frame: within 6 months after the end of the follow-up period ] [ Designated as safety issue: No ]
  • Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA [ Time Frame: within 3 months of the end of the follow-up period ] [ Designated as safety issue: No ]
  • Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information [ Time Frame: within one year after the end of the follow-up period ] [ Designated as safety issue: No ]
  • Feasibility and safety data on nCLE during EUS-FNA procedure [ Time Frame: Within 3 months after the end of the enrollment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lymph nodes, pancreatic masses & cysts Procedure: EUS-FNA
Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
Other Names:
  • ultrasonographic endoscopy
  • EUS-guided FNA
Device: nCLE
needle-based Confocal Laser Endomicroscopy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female > 18 years of age.
  • Patient indicated for a first EUS-FNA for a pancreatic cyst, lymph node or pancreatic mass, or
  • Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst, lymph nodes, pancreatic mass, more than three months ago.
  • Patient with known pancreatic cyst or mass detected at cross-sectional imaging or suspicious lymph nodes reachable via EUSFNA
  • Willing and able to comply with study procedures and provide written informed consent to participate in the study.

Add for lymph nodes:

- any lymph node reachable with EUS-FNA

Add for pancreatic mass:

  • any size
  • any location in the pancreas

Exclusion Criteria:

  • Subjects for whom EUS-FNA procedures are contraindicated
  • Known allergy to fluorescein dye
  • If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding

Add for cysts:

  • Subject with multiple cysts
  • size < 20mm in diameter
  • previous EUS-FNA procedure performed less than 3 months ago - Patients suffering chronic calcifying pancreatitis

Add for lymph nodes:

  • size < 5mm in diameter
  • If patients present several suspicious lymph nodes, only one of them will be imaged during the nCLE procedure

Add for pancreatic mass:

- If patient present several pancreatic masses, only one of them will be imaged during the nCLE procedure

  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: NCT01563133

Contacts
Contact: Marc Giovannini, MD giovanninim@wanadoo.fr

Locations
France
Hôpital Saint-Philibert Recruiting
Lomme, France, 59462
Sub-Investigator: Bernard Filoche, MD, PhD         
Principal Investigator: Damien Lucidarme, MD, PhD         
Hôpital Jean Mermoz Recruiting
Lyon, France, 69008
Principal Investigator: Bertrand Napoléon, MD         
Sub-Investigator: Bertrand Pujol         
Institut Paoli Calmettes Recruiting
Marseille, France, 13273
Principal Investigator: Marc Giovannini, MD         
Sub-Investigator: Fabrice Caillol         
Sponsors and Collaborators
Mauna Kea Technologies
Investigators
Principal Investigator: Marc Giovannini, MD Institut Paoli-Calmettes
  More Information

Publications:
Waxman, I., Aslanian, H.R., Konda, V.J., Siddiqui, U.D., Wallace, M.B. First Assessment of Needle-based Confocal Laser Endomicroscopy (nCLE) During EUS-FNA Procedures of the Pancreas. Gastoint Endosc 2011; 74:5; 1049-1060

Responsible Party: Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT01563133     History of Changes
Other Study ID Numbers: MKT-2012-nCLE-02
Study First Received: March 22, 2012
Last Updated: April 24, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Mauna Kea Technologies:
endomicroscopy
needle-based
pancreatic
cyst
mass
EUSFNA

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neuroendocrine Tumors
Pancreatic Cyst
Cysts
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014