In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors (INSPECT)

This study has been completed.
Sponsor:
Collaborators:
Mauna Kea Technologies
Institut Paoli-Calmettes
Technische Universität München
Yale University
University of California, Irvine
Mayo Clinic
University of Washington
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01236300
First received: November 5, 2010
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinous cysts)


Condition Intervention
Pancreatic Cysts
Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Image interpretation criteria [ Time Frame: October 2011 ] [ Designated as safety issue: No ]
    The primary aim of the INSPECT study is to define descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts, and then to identify those criteria which have the best diagnostic accuracy retrospectively


Secondary Outcome Measures:
  • Safety [ Time Frame: August 2011 ] [ Designated as safety issue: Yes ]
    Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure

  • Technical feasibility [ Time Frame: August 2011 ] [ Designated as safety issue: No ]
    Assess the technical feasibility of nCLE: rate of interpretable images, technical ease of insertion and extraction of the nCLE probe in the needle, technical problems

  • Image atlas of nCLE [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
    Build an atlas of nCLE images in the pancreas


Enrollment: 65
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cellvizio system Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system

Detailed Description:

The primary aim of the study is to define interpretation criteria to differentiate mucinous from non-mucinous cysts and classify more precisely the cysts. Once these criteria have been defined, the diagnostic parameters of nCLE in differentiating the different types of cysts and the reproducibility of these criteria will be assessed.

  Eligibility

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

Inclusion Criteria:

  • Patients scheduled for an EUSFNA procedure of a pancreatic cyst,
  • Patients aged 18 years or older,
  • Patients is under surgical consideration for management of the cyst
  • Patients have provided written informed consent for the study

Exclusion Criteria:

  • Allergy to fluorescein
  • Pregnancy or breast-feeding
  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: NCT01236300

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, IL 60637
Sponsors and Collaborators
University of Chicago
Mauna Kea Technologies
Institut Paoli-Calmettes
Technische Universität München
Yale University
University of California, Irvine
Mayo Clinic
University of Washington
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Irving Waxman, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01236300     History of Changes
Other Study ID Numbers: MKT-2010-INSPECT, EUSFNA_02
Study First Received: November 5, 2010
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University of Chicago:
Pancreatic cysts

Additional relevant MeSH terms:
Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014