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: May 6, 2016
Last verified: May 2016
  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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Sensitivity [ Time Frame: October 2011 ] [ Designated as safety issue: No ]

    Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.

    For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.

    In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.


  • Specificity [ Time Frame: October 2011 ] [ Designated as safety issue: No ]

    Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.

    For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.

    In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.


  • PPV (Positive Predictive Value) [ Time Frame: October 2011 ] [ Designated as safety issue: No ]

    Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.

    For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.

    In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.


  • NPV (Negative Predictive Value) [ Time Frame: October 2011 ] [ Designated as safety issue: No ]

    Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.

    For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.

    In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.



Secondary Outcome Measures:
  • Overall Complication Rate [ 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


Enrollment: 66
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
Experimental: 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   (Adult, Senior)
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

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
Results First Received: February 12, 2015
Last Updated: May 6, 2016
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
Pancrelipase
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 28, 2016