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

November 5, 2010
May 6, 2016
July 2010
August 2011   (final data collection date for primary outcome measure)
  • 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.

nCLE interpretation criteria to classify the cysts and to differentiate mucinous from serous cysts. [ Time Frame: April 2011 ] [ Designated as safety issue: No ]
The acquired data will be reviewed and compared to the standard result (either EUS+/-FNA and/or surgical pathology), in order to first define descriptive criteria for each type of encountered cyst, and to infer which interpretation criteria have a good enough predictive value to differentiate mucinous and benign cysts. These potential diagnostic criteria will then be tested by reviewing sequences retrospectively for the already acquired data and prospectively for the remaining patients.
Complete list of historical versions of study NCT01236300 on ClinicalTrials.gov Archive Site
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
Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and EUS-FNA accuracy in the differential diagnosis of cysts. [ Time Frame: April 2011 ] [ Designated as safety issue: No ]
Evaluate the sensitivity,specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of differentiating mucinous from serous cysts with nCLE will be determined, and the value of nCLE in the diagnosis of cysts will be assessed.
Not Provided
Not Provided
 
In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
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)
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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pancreatic Cysts
Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system
Experimental: Cellvizio system
Intervention: Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
France,   Germany
 
NCT01236300
MKT-2010-INSPECT, EUSFNA_02
Yes
Not Provided
Not Provided
University of Chicago
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
Principal Investigator: Irving Waxman, MD University of Chicago
University of Chicago
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP