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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):
Vani Konda, University of Chicago
ClinicalTrials.gov Identifier:
NCT01236300
First received: November 5, 2010
Last updated: January 14, 2013
Last verified: January 2013
History of Changes

November 5, 2010
January 14, 2013
July 2010
August 2011   (final data collection date for primary outcome measure)
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
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
  • 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
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: Needle-based Confocal Laser Endomicroscopy (nCLE)

Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure.

The nCLE probe will be positioned against the lining of the pancreatic cyst, and sequences will be acquired. After nCLE imaging, fine needle aspiration of the lesion will be performed, as usual.

Other Names:
  • Cellvizio
  • pCLE
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
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
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany
 
NCT01236300
MKT-2010-INSPECT, EUSFNA_02
Yes
Vani Konda, 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
January 2013

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